daily bulletin - American Thoracic Society

Transcription

Denver, Colorado
DAILY
BULLETIN
6 SLEEP APNEA
8 CANCER SCREENING
MONDAY
M AY 1 8 , 2 0 1 5
Where today’s science meets tomorrow’s care™
21 SCIENCE AWARDS
Question of the Day
Opening Ceremony Blends ATS Highlights and Humor
What are you looking for in
T
in your research or clinical
he ATS 2015 International Conference opened with a mix of highlights
of the Society’s programs and standup
comedy Saturday evening as ATS leaders
reviewed milestones and recognized a variety
of accomplishments before The Daily Show
Senior Correspondent Aasif Mandvi offered
his punchy take on science, politics, and race.
ATS President Thomas Ferkol, MD, welcomed attendees to Denver and noted the
importance of Colorado in ATS history.
“As many, but perhaps not all, of you
know, the Society began in 1905 as the
American Sanatorium Society, which was
established to promote the treatment and
prevention of tuberculosis,” Dr. Ferkol said.
“Around that time, thousands of people
with tuberculosis were moving to Colorado,
believing the clean air was an effective treatment strategy.”
As the ATS celebrates its 110th anniversary,
the Society has become an international organization focusing on patient care and research
in adult and pediatric pulmonary, critical
care, and sleep medicine, Dr. Ferkol said. This
year’s conference reflects that growth with the
introduction of the ATS Discoveries Series, a
collection of lectures from leading scientists
care?
“New technology advances that may help
in the development of
new drugs to help with
disease.”
Reinilde Heyrman, MD
Neshanic Station, NJ
ATS President Thomas Ferkol discusses Society highlights during the Opening Ceremony Saturday.
and clinicians about scientific and clinical
breakthroughs.
The work of several ATS members and
groups was recognized during the session. Dr.
Ferkol discussed the creation of the ATS Academy to support early career professionals, as
well as the first class of ATS Scholars and ATS
Educators. He also praised the development
of the ATS Section on Medical Education that
supports the development of teaching skills to
all members of the society. And he acknowledged the development of the ATS Fellow-
ship in Health Equality and this year’s Health
Equality Award winners, Juan C. Celedón, MD,
MPH, DrPH, and Alysa Ellis, MD.
Dr. Ferkol also praised the ATS Foundation,
which has awarded $11 million in grants to 183
investigators in the 10 years since the launch of
the Foundation Research Program.
“With the help of this seed money, these
investigators have gone on to win a total of
$143 million in major grants, and many have
published original research in high-impact
see OPENING CEREMONY page 26
ATS Discoveries Series Today: Lung Regeneration, TB
T
oday’s Discoveries
Series lectures will
cover lung regeneration and tuberculosis.
The lectures, which will
chart seminal clinical and
scientific breakthroughs,
will be given concurrently Darrell Kotton
from 8:30 to 9:15 a.m. The
Discoveries Series is presented in celebration of the American Thoracic Society’s
110th anniversary.
LUNG REGENERATION: AN
ACHIEVABLE MISSION
Four Seasons Ballroom 1-2 (Lower Level),
Colorado Convention Center
the Exhibit Hall to help you
Darrell Kotton, MD,
director of regenerative
medicine at Boston University, is optimistic about
the prospect for lung regeneration with new tools
and a better understanding of the lung and how it
Trevor Mundel
responds to injury.
“The great hope is that we can move
beyond our current approach of minimizing harm to actual reparative therapies,
where we regenerate lungs and make people
better,” Dr. Kotton says.
In a Pulmonary Perspective article
published in the June 15, 2012, American Journal of Respiratory and Critical
Care Medicine, titled “Next-Generation
Regeneration: the Hope and Hype of Lung
Stem Cell Research,” Dr. Kotton surveyed
three broad areas scientists in the field are
advancing:
• Understanding lung epithelial responses
to injury;
• Developing tissue-specific candidate
lung stem/progenitor cells with the
capacity for broad differentiation;
• Exogenous derivation of lung epithelia from embryonic stem (ES) cells or
induced pluripotent stem (iPS) cells.
Dr. Kotton’s research focuses on iPS
cells, which sidestep the political and ethical barriers to ES cell research. Induced
see DISCOVERIES page 27
“I’m a researcher, and
I’m very interested
in imaging devices,
including ultrasound
and CT scans.”
Yimu Yang, MD, PhD
Aurora, CO
“I’m a pulmonologist,
and I think the pleurx
catheter is efficacious.
Patients can be taught
how to unclamp and
drain them at home
when they start to get
short of breath or feel like fluid is building
up. It cuts down on costs because you
don’t have someone coming into the
clinic or hospital. It’s also more comfortable for patients and has less risk of
infection.”
Angel Brown, MD, BSN
Birmingham, AL
“Mostly for my clinical
practice, I’m looking
for information about
new medications and
devices.”
Mohamed Zeitouni, MD
Brooklyn, NY
“I’m a clinician, and
I’m looking for new
technology, such as
new noninvasive
monitoring.”
Dora Alvarez, MD
Passaic, NJ
FREEr and
White Pape
COPD Program
Preview
Nonin_ATS Daily Bulletin Ad-2.indd 1
4/29/2015 1:43:16 PM
2
ATS Daily Bulletin • ATS 2015 International Conference • Monday May 18, 2015
Q&A : ATS President Thomas Ferkol, MD
An interview with
Thomas Ferkol, MD,
ATS President
Q
: What have you found most gratifying
during your term as president?
A: I take pride in what the American Thoracic Society has accomplished this year. Our
membership is diverse, which is the strength
of our Society, and we expanded programs
to encourage and promote our early career
colleagues in their varied academic pursuits
vital to our mission. The fruition of the ATS
Academy has been particularly gratifying. We
will name the first class of ATS Scholars and
ATS Educators at the upcoming International
Conference, recognizing our younger members who have either received awards or have
been recognized by their own assemblies for
their accomplishments in research or medical
education. In addition, we invested even more
funds into the ATS Foundation grants program to support young physician-scientists as
they begin their careers.
I am pleased to see the culmination of our
110th anniversary in the Discoveries Series,
which has given us the opportunity to do
something truly different. The ATS journals
and ATS 2015 International Conference have
coordinated their efforts to highlight many
of the advances in patient care and research
in adult and pediatric pulmonary, critical
care, and sleep medicine. The ATS Discoveries Series is a new collection of articles and
talks that features major scientific and clinical
breakthroughs, which have changed the lives
of the patients we treat, as told by leading scientists and clinicians. The program allows us
to highlight where we have been and what we
have achieved, but more important where we
are going, which will have the greatest value
to the practice of medicine.
Finally, we’ve also made great strides in increasing our visibility, which we have accomplished by coordinating our communications
efforts, upgrading our website, increasing
our social media activities, and producing an
annual report. All of these initiatives tell our
story much more efficiently and effectively
than we have in the past.
Q
: In your role as president, what have
you witnessed as being a big challenge
to the fields of pulmonary, critical care, and
sleep medicine?
A: It must be the shrinking number of
individuals who are interested in pursuing
academic careers worldwide. Whether you
are talking about individuals who are entering
a career as physician-scientists or educators
teaching tomorrow’s leaders, thus defining the
course of the next generation of physicians
and other health professionals, the numbers
Former Surgeon General Speaks
are quite worrisome. With fewer entering pulmonary research, who will make the discoveries that will lead to scientific breakthroughs
and novel treatments for children and adults
with lung diseases? Without teachers, who
will train the next generation and allow them
to understand the many opportunities that
exist in research? Who will advocate for the
patients we treat? It is a threat that we must
address.
I hope that the ATS Academy and a new
initiative, ATS Global Scholars, which was
introduced by President-Elect Atul Malhotra,
MD, during the Opening Ceremony, will begin a larger effort to draw the best and brightest into our fields. These programs are early
but necessary steps in the right direction.
Q
: Can you speak to the value of collaboration between the ATS and its sister
societies throughout the world?
A: Only after I began my tenure four years ago
did I grasp how global the American Thoracic
Society was. Historically, the Society has supported the creation of respiratory societies,
and we have maintained strong relationships
with our partners around the world. Consequently, I have been on the road quite a bit
this past year, visiting with our sister societies,
including the Japanese Respiratory Society,
British Thoracic Society, Canadian Thoracic
Society, Chinese Association of Chest Physicians, Asian Pacific Society of Respirology,
Brazilian Thoracic Society, and Turkish Thoracic Society, to name just a few. Our visits
this past year have helped to further cement
these friendships.
These experiences have only confirmed my
belief that the voice of many is more powerful than the voice of one, as evidenced by the
Forum of International Respiratory Societies (FIRS), of which the American Thoracic
Society is a founding member. The Forum is
comprised of the leading international respiratory societies and together enhances our
efforts to improve global lung health. This collaboration led to our invitation to the United
Nations High-Level Review on the Prevention
and Control of Non-communicable Diseases
in July 2014, and we continue our work with
the Forum and the Non-communicable Disease (NCD) Alliance to reduce the burden of
pulmonary diseases worldwide.
Q
: What do you hope to accomplish in
your upcoming role as immediate past
president?
A: As the immediate past president, my
responsibility will be to ensure continuity and
provide “institutional memory” for the Executive Committee and the Board of Directors.
Atul and I have spoken nearly every week this
year, so the transition will be smooth. Indeed,
many of his plans and goals for this year build
on our recent efforts. I think they are all really
quite laudable.
Question of the Day
What are you looking for in the Exhibit Hall to help you in your
research or clinical care?
I’m a clinician-researcher,
and we’re looking for more
efficient ways of making a
diagnosis, so I’m looking
for any new diagnostic
therapeutic products and
medications that can help
our patients.”
Rahul Argula, MBBS, MPH
Charleston, SC
“I’m interested in new modalities to deliver treatment
options as well as variable
forms of inhaler therapy,
new broncoscopic treatment options, and things
like that for my clinical
practice.”
Sheri Tran, MD
San Diego
JAMA, NEJM Editors Discuss Research Papers
Diversity Forum attendees chat with guest speaker Richard H. Carmona (right), MD, MPH, FACS,
17th Surgeon General of the United States; vice chairman, Canyon Ranch; president, Canyon
Ranch Institute; and Distinguished Professor, University of Arizona, Tucson. During the Sunday
forum, 20 talented individuals also received Minority Trainee Diversity Scholarships.
An attendee poses a question during
the New England Journal of Medicine
and the Journal of the American Medical
Association “Discussion on the Edge”
session. Eight papers about pulmonary
and critical care research published by
the New England Journal of Medicine
and the Journal of the American Medical
Association were discussed in separate
sessions Sunday. In the Pulmonary
Research session, Jeffrey M. Drazen,
MD, NEJM editor-in-chief, and George T.
O’Connor, MD, MS, JAMA associate editor, discussed four papers and answered
questions from the audience. In the
Critical Care Research session, Derek C.
Angus, MD, MPH, JAMA associate editor, and Dr. Drazen reviewed four more
papers.
Gilead is committed
to expanding healthcare
options for individuals living with
cardiovascular and respiratory diseases
through innovative research, access,
and education programs.
© 2013 Gilead Sciences, Inc. All rights reserved. UNBP0196 August 2013
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc.
4
Donors Dance and Dine in Support of Respiratory Research
A
TS 2015 attendees gathered for a
special evening reception Saturday
when the ATS Foundation kicked
off its Seventh Annual ATS Foundation
Research Program Benefit.
The gala, featuring music, dancing, and
food stations, celebrated the Foundation’s
10th anniversary and the launch of countless highly successful research careers. In
addition, the Research Program Benefit has
raised a record-breaking $500,000 for the
Foundation.
More than 600 attendees gathered at the
Hyatt Regency Denver to socialize with
friends; honor grant awardees; recognize
Marvin Schwarz, MD, the recipient of the
2015 Breathing for Life Award; and celebrate
the ATS Foundation’s Research Program
successes of the past 10 years.
Since 2004, the ATS Foundation has provided $11 million in grants to more than 183
junior investigators, launching the careers of
a new generation of researchers.
“Our investigators have attracted more
than $143 million in subsequent grant funding, published hundreds of articles relevant
to their ATS Foundation awards and have,
in turn, become mentors,” says James F.
Donohue, MD, chair of the ATS Foundation
Board of Trustees.
In 2015, the ATS Foundation will fund
more than 20 awards, including unrestricted
research awards in pulmonary, critical care,
and sleep medicine; research partner awards;
and awards for outstanding alumni from
the Methods in Epidemiologic, Clinical and
Operations Research Program. Applications
for the 2015 Research Program are being
accepted now, with letters of intent due by
June 5, 2015.
“Through the funds raised yesterday, we
hope to continue to help protect struggling
young investigators who represent the future
of our profession,” Dr. Donohue says.
“In its second decade, the ATS Foundation would like to build on the successes of
the Research Program,” Dr. Donohue adds.
“Through the 10th Anniversary Campaign,
we propose to raise $3 million over the next
three years, launching the careers of earlystage investigators dedicated to scientific
discovery and better patient care.”
Dr. Schwarz was presented with the 2015
Breathing for Life Award, the highest honor
given by the ATS Foundation for philanthropy and mentoring of young investigators.
Dr. Schwarz is a legend in pulmonary
medicine, particularly in the field of pulmonary fibrosis. His level of expertise has led
many fellows and seasoned clinicians to try
(usually unsuccessfully) to “Stump Marvin
Schwarz” with a difficult case at the ATS Fellows Case Conference.
Grateful for the dedicated mentorship
he received under Morton Ziskind, MD, at
Tulane University, Dr. Schwarz has paid it
ATS Journals Cover the Entire
Spectrum All Year Long
Want comprehensive coverage of the latest advances in
adult and pediatric pulmonary, critical care, and sleep
medicine beyond the ATS 2015 International Conference?
Look no further than the journals of the American Thoracic
Society, published all year long and constantly improving:
ATS Journals App
for ANDROID
Now Available!
James F. Donohue (left), the ATS Foundation Board of Trustees chair, presents the 2015 Breathing for Life Award to
Marvin Schwarz.
forward by mentoring more than 150 physicians and scientists, including Talmadge
King Jr., MD, the 2012 Breathing for Life
awardee.
“Marvin’s commitment to better understanding of the causes and treatment
of interstitial lung disease has been with-
WHAT TO EAT & DRINK
AT ATS 2015
BISTRO
ATS
American Journal of Respiratory and Critical Care Medicine
• New Fast-Tracked Clinical Trial
Protocol Review
• New Early Career Group
• New State-of-the-Art Articles
• New Update Series Articles
• Podcasts, Videos, and More HighQuality Graphics and Charts
• New Discoveries Series Celebrating
the ATS 110th Anniversary
• Blue Editor on Twitter: @ATSBlueEditor
American Journal of Respiratory Cell and Molecular Biology
• First Decision in 18 Days
• More High Quality Graphics and
Charts
• Junior Investigator Award to Highlight
Best Paper
• New Research and Correspondence
Letters
Annals of the American Thoracic Society
• New ATS Core Curriculum Series
(CME, ABIM, and ABP MOC
Opportunities)
• New ATS Clinical Practice Guideline:
Summary Series (CME, MOC
Opportunities)
• Podcasts, Videos, and More HighQuality Graphics and Charts
• AnnalsATS Editor on Twitter:
@AnnalsATSEditor
Read the ATS journals today at atsjournals.org
out peer,” says Dr. King. “In addition, he
spawned a generation of others’ interests in
the disease.”
Dr. Schwarz oversaw the Fellowship Program of the Pulmonary Sciences and Critical
Care Medicine Division at the University of
see FOUNDATION page 8
The
Hydration
Stations
BREATHE
EASY
BAR
A well-balanced buffet lunch
including beverages and dessert
located in the Exhibit Hall. Tickets
available at ATS registration and
at the Bistro ATS.
Fill up your ATS water bottle from
one of 15 water coolers or 22
water fountains located around
the Colorado Convention Center.
Supported by Gilead Sciences, Inc.
Unwind after a full day at this Happy
Hour hot spot in Lobby B. Help
benefit the ATS Foundation with the
purchase of the Marvin Schwarz
signature drink. Open from 3:00
p.m. to 6:00 p.m. on Sunday,
Monday, and Tuesday. Sponsored
by MEDA Pharmaceuticals.
5
ATS Develops Decision Aid for Lung Cancer Screening with CT
I
n February, the Centers for Medicare &
Medicaid Services issued its final coverage
policy for CT lung cancer screening under
Medicare, allowing coverage of annual lowdose CT lung cancer scans for beneficiaries
who meet specific criteria.
“This is the first time that Medicare has
required a decision aid and the use of shared
decision-making for reimbursement of a
screening test,” says Renda Wiener, MD,
MPH, who as a member of the ATS Thoracic
Oncology Assembly developed and reviewed
the Decision Aid with Christopher Slatore,
MD, MS, chair; Doug Arenberg, MD; and
Marianna Sockrider, MD, DrPh, ATS medical
editor for patient education.
Dr. Wiener attributes the impetus for the
CMS policy requiring use of a decision aid
to evidence about the benefits and harms
of screening. The National Lung Screening
Trial showed a 20 percent reduction in lung
cancer mortality with annual CT screening,
but the trial also showed a high false-positive
rate—pulmonary nodules requiring further
evaluation were detected in about 40 percent
of patients.
Physicians can use this tool, which is available at thoracic.org and will be on hand at the
Assembly of Thoracic Oncology meeting from
5 to 7 p.m. tonight at the Hyatt Regency Denver, to help patients systematically go through
the pros and cons of lung cancer screening.
“We designed the Decision Aid with language and visuals that are easy for patients to
understand. It’s a useful tool to help guide the
discussion about the tradeoffs of lung cancer
screening and to achieve the shared decisionmaking that is necessary for Medicare reimbursement,” says Dr. Wiener, assistant professor of medicine at Boston University and an
investigator at Edith Nourse Rogers Memorial
Veterans Hospital, Bedford, MA.
The Decision Aid describes all of the
considerations for lung cancer screening,
including the resources for smoking cessation, benefits of screening, symptoms of lung
cancer, risk factors for lung cancer, research
about the benefits of screening, harms of screening,
physician interventions to
prevent screen harms, and
screening process.
“Although 95 percent of
nodules detected through
screening turn out to be
false-positive results, the
Renda Wiener
evaluation process can
expose patients to harm,” Dr. Wiener says.
“That includes anxiety and distress about
undergoing radiographic surveillance and not
knowing whether they have cancer, physical
complications for those needing a biopsy, and,
in the worst-case scenario, the possibility of
unnecessary surgery to remove a nodule that
is thought to be malignant and turns out to be
benign. Surgery, of course, has the potential
for complications, including death.”
The high false-positive rate could be attributed to variability in CT scan readings.
“There is a large effort to standardize the
way that CT scans are read using a structured
reporting system, such as Lung-RADS that
has been proposed by the American College
of Radiology,” Dr. Wiener says.
CRITERIA FOR
MEDICARE
REIMBURSEMENT
M
edicare will cover lung cancer
screening with low-dose CT
once per year for Medicare
beneficiaries who meet all of the following
criteria:
• They are age 55–77, and are either current
smokers or have quit smoking within the
last 15 years;
• They have a tobacco smoking history of at
least 30 “pack years” (an average of one
pack a day for 30 years); and
• They receive a written order from a physician or qualified non-physician practitioner
that meets certain requirements.
Medicare coverage includes a visit for
counseling and shared decision-making
on the benefits and risks of lung cancer
screening. The National Coverage Determination also includes required data collection and specific coverage eligibility criteria for radiologists and radiology imaging
centers, consistent with the National Lung
Screening Trial protocol, U.S. Preventive
Services Task Force recommendations,
and multisociety, multidisciplinary stakeholder evidence-based guidelines.
It pays to be an
ATS MEMBER
The American Thoracic Society:
•
•
•
•
•
Advances respiratory science
Fosters scientific exchange & dialogue
Disseminates knowledge
Provides guidance on clinical care
Supports young professionals
•
•
•
•
Enhances public health
Promotes global health
Advances patient care
Nurtures local collaboration through its chapters
Not an ATS member? You could be!
Join at the ATS Center here in Denver. Not only will you save on your International Conference
registration* but you will also benefit from:
• Subscriptions to three cutting-edge medical journals**,
• Membership in up to three ATS Assemblies – choose from 14 assembly “interest groups” in your
area of practice that help set standards for medical care,
• Professional development – at member rates – at the International Conference,
• Additional learning opportunities and networking at chapter meetings,
• Local and global advocacy efforts that benefit you and your patients,
• Career development programs and services.
Members save more than $1,000 on ATS products and services.
* You must join ATS before registering for the conference to receive the discounted registration rate.
** Some journals are delivered electronically only.
ATS 2015
If you have an ATS question while you are in Denver, visit
the ATS Center or send a text message to 929-224-4411
and staff will reply to you promptly.
BONUS:
1. Fellows/trainees receive their first year of
membership for FREE, and international members
pay reduced member rates.
2. Join or renew your membership at the ATS Center
and receive a FREE conference T-shirt.
Visit the ATS Center in the Exhibit Hall,
booth #725 or in the F Atrium (Street Level)
of the Colorado Convention Center.
6
Sleep Apnea Session Delves into New Approaches for Patient Selection
P
resenters of a Monday afternoon
scientific symposium will discuss
the state of the art of personalized
medicine for obstructive sleep apnea (OSA).
“Currently, the vast majority of patients
with OSA are treated with nasal continuous positive airway pressure (CPAP), which,
although effective, is poorly tolerated by
most patients and is unacceptable to many,”
says David White, MD, a professor of sleep
medicine at Harvard Medical School and
a senior physician in the Division of Sleep
Medicine at Brigham and Women’s Hospital, Boston.
“Although there are other potential therapies, most only work in a sub-segment of
OSA patients with no real way, other than
trial and error, to determine in whom these
therapies might be effective. Thus many
patients remain untreated,” Dr. White adds.
Dr. White and Allan Richard Schwartz,
MD, professor of medicine at Johns Hopkins University, Baltimore, are co-chairs of
“Personalized Medicine for Sleep Apnea:
State of the Art” from 2:15 to 4:15 p.m. in
Mile High Ballroom 2B/3B (Lower Level)
Colorado Convention Center.
Speakers will discuss novel ways to determine why a given patient has OSA, with
four traits dictating those with and without
OSA:
• Pharyngeal anatomy and site of collapse
• Upper airway muscle control asleep
• Respiratory arousal threshold
• Loop gain (ventilator control instability)
“With this knowledge, therapies can be
targeted at the individual
pathology with reasonable
expectations for success,”
says Dr. White, adding
that such therapies can include devices, surgery, and
drugs, which can be used
alone or in combination to David White
achieve optimal results.
Symposium speakers will address sophisticated pharmaceutical approaches to OSA
therapy, as well as more standard ones, such
as surgery and oral appliances.
“This is a fundamental change in the approach to OSA therapy, which to date has been
‘one size fits all,’ plus ‘trial and error.’ It also will
allow the introduction of new therapies, which
previously would not have been considered
reasonable options,” Dr. White says.
For additional programming concentrating on sleep-disordered breathing in
personalized medicine, plan to attend
today’s abstract-based mini symposium
“Picking Winners. Predicting Response
to Treatment of Sleep-Disordered Breathing in an Era of Personalized Medicine”
and Wednesday’s symposium “Impact of
Sleep-Disordered Breathing on Maternal
and Fetal Outcomes of Pregnancy.” Both
will be from 9:30 to 11:30 a.m. in Mile High
Ballroom 2B/3B (Lower Level) Colorado
Convention Center.
Try New Apps
and Grab Print
Journals
B
rowse the latest iPad apps from
leading publishers and pick up
free copies of medical journals
and news magazines at the ATS 2015
Journal & Magazine Annex in Lobby A
(Street Level) in the Colorado Convention
Center.
EACH IPAD KIOSK FEATURES
FULL ACCESS TO:
•
•
•
•
•
ATS Journals
ERS Publications
JAMA Network Reader
Journal of Hospital Medicine
Journal of Thoracic and
Cardiovascular Surgery
• NEJM iPad Edition
• Sleep Medicine Journals
FREE IN THE ANNEX:
• American Journal of Respiratory and
Critical Care Medicine
• American Journal of Respiratory Cell
and Molecular Biology
• Annals of the American Thoracic
Society
• Annals of Internal Medicine
• Clinical Respiratory Journal
• European Respiratory Journal
• European Respiratory Reviews
• Journal of Applied Physiology
• Journal of Cystic Fibrosis
• Journal of Hospital Medicine
• Journal of Pediatrics
• Journal of the American Medical
Association
• Journal of Thoracic and
Cardiovascular Surgery
• The Lancet
• The Lancet Respiratory Medicine
• Lung Cancer
• New England Journal of Medicine
• Paediatric Respiratory Reviews
• Pediatric Pulmonology
• Respiration
• Respiratory Medicine
• Sleep Medicine
• Sleep Medicine Reviews
• Thorax
ATS_2015 Daily Bulletin Ad:ATS 5/1/15 11:08 AM Page 1
You are cordially invited to attend an evening symposium
EXPERT PERSPECTIVES: A HANDS-ON
LOOK AT A CHANGING PAH LANDSCAPE
Nick Kim, MD, Program Chair
University of California, San Diego
La Jolla, California
Welcome, Introductions, and PAH Overview
Tuesday, May 19, 2015
6:30 PM–7:00 PM Registration and Dinner
7:00 PM–8:30 PM Symposium
University of California, San Diego
La Jolla, California
PAH: Clinical Practice vs. Clinical Trials
Sheraton Denver Downtown
Plaza Ballroom DEF, Concourse Level,
Plaza Building
1550 Court Place
Denver, Colorado
16
th
St
Pl
St
on
th
Sheraton Denver
Downtown
m
ar
an
Tr
13
em
on
tP
l
Gl
St
Grant St
th
Sherman St
14
Lincoln St
Broadway
Pl
W
elt
Disease Progression in PAH:
Key Learnings from Recent Analyses
E. 17th St
15
Colorado
Convention Center
Nick Kim, MD
tP
Co
ur
St
l
th
W. Colfax Ave.
E
Colorado State Capitol
Civic Center Park
W. 14th Ave
Dinner will not be provided to physicians and other healthcare professionals
licensed in Vermont or other states where gifts and meals are prohibited. Dinner
provided to physicians will be subject to reporting under Federal law. We regret
that spouses and other guests may not be accommodated.
Sean Gaine, MD, PhD
Mater Misericordiae University Hospital
University College Dublin
Dublin, Ireland
Ronald Oudiz, MD
Los Angeles Biomedical Research
Institute at Harbor-UCLA Medical Center
Torrance, California
Panel Discussion
All Faculty
Concluding Remarks
An Industry-Organized Symposium at the ATS 2015 International Conference. A
non-CME educational program sponsored by Actelion Pharmaceuticals US, Inc.
Open to all ATS 2015 International Conference attendees.
Register on-site or online at: www.PAHsymposium.com
©2015 Actelion Pharmaceuticals US, Inc.
All rights reserved. ACT-00802 0415
8
Controversies in Lung Cancer
Screenings Put to Pro/Con Debate
FOUNDATION
Continued from page 4
Colorado Medical Center and also served
as head of the division. Although he
stepped down as division director several
years ago, he hasn’t hung up his lab coat.
At age 75, he remains committed to his
he National Lung Screening Trial
research.
(NLST) demonstrated a 20 percent
Dr. Schwarz believes in the ATS Founrelative reduction in lung cancer specific
mortality
with the use of annual lowdation’s mission of fostering the career
dose CT scans. Current guidelines from the
development of young investigators.
ATS and other organizations recommend
“The Research Program is vitally imthat screening should be offered to those
portant, offering seed funding to junior
at high risk of developing lung cancer. The
investigators encouraging them to pursue
Centers for Medicare and Medicaid Services
careers in lung research,” says Dr. Schwarz.
and other insurance providers now cover
“Without a steady pipeline of investigalung cancer screening. However, given the
tors leading the way, research will stall and
high false-positive rate, significant concerns
patients will suffer.”
remain about the harms of screening and
The ATS Foundation thanks the many
individuals and 27 medical institutions that whether the results of the NLST will translate to improvements in mortality among
have stepped forward to support the Repatients in routine clinical care. Most health
search Program during a difficult financial
systems are at various stages of developing
climate for research.
screening programs.
The ATS Foundation thanks Genentech
The session “Controversies in Lung
for support at the Sapphire Level; BoehCancer
Screening: Pro/Con Debate” from
ringer Ingelheim Pharmaceuticals, Inc., and
9:30 to 11:30 a.m. today in Room 605/607
Genentech-Novartis at the Platinum Level;
(Street Level) Colorado Convention Center
AstraZeneca LP and the University of Colowill explore the tradeoffs benefits and harms
rado Health at the Gold Level; Freeman,
of screening.
MEDA Pharmaceuticals, Inc., and Teva
“Lung cancer screening can provide benRespiratory at the Silver Level.
efit,
but it can also cause harm. More people
For the most up-to-date list of generous
are harmed by screening than are helped,
donations from individuals, medical instituand one of the primary goals is to reduce
tions, and corporate supporters of the ATS
and severity of that harm.
Foundation,
visit
foundation.thoracic.org.
02.ATS PILOT daily ad.qxp_Layout 1 4/28/15 3:29 the
PM frequency
Page 1
T
An Industry-Organized Symposium at the ATS 2015 International Conference
TRANSLATING IPF CLINICAL TRIALS TO
REAL LIFE PATIENTS
A CASE-BASED SYMPOSIUM
TUESDAY, MAY 19, 2015 • 6:30–9:30 PM
Silverton Ballroom • Embassy Suites Denver–Downtown/Convention Center
Register at:
francefoundation.com/denver
AGENDA & FACULTY
TARGET AUDIENCE: A non-CmE educational
6:30 pm
Gather and Dinner
program sponsored by The France Foundation open
to all ATS 2015 International Conference attendees.
6:45 pm
Welcome and Introductions
STATEMENT OF NEED: Care of patients with IpF has
LUCA RICHELDI, MD, PhD (Chair)
University of Southampton
Newly Available Therapies:
Discussing the Difficult Questions
LUCA RICHELDI, MD, PhD
7:30 pm
Selecting the Right Treatment: Which
Patients and When to Start Treatment?
HAROLD R. COLLARD, MD
University of California, San Francisco
8:00 pm
Switching Drugs: When, and is There
a Time for Change in Therapy?
KEVIN K. BROWN, MD
National Jewish Health
8:30 pm
Managing Side Effects and Dosing:
Need for Individualized Strategies?
MARILYN K. GLASSBERG, MD
University of miami miller School of medicine
9:00 pm
screening should be available at all centers, if
biomarkers are ready for clinical use, and if
overdiagnosis is a real problem.
“The topics are designed
to provide a framework for
how to weigh the benefits
and risks about lung cancer
screening implementation
so that attendees can use
them when designing their
Christopher Slatore own programs,” Dr. Slatore
says.
If this session interests you, don’t miss
“Inflammatory Signaling Pathways Linking COPD and Lung Cancer: New Peaks
on the Rocky Climb to a Cure” from 9:30
to 11:30 a.m. Wednesday in Room 605/607
(Street Level) Colorado Convention Center.
Speakers will discuss novel insights into
the biological links between COPD and
lung cancer, the role of NF-kB pathway in
carcinogen-induced lung cancer, the role
of tumor-associated neutrophils in lung
tumorigenesis, and cigarette smoke, COPD,
and lung cancer.
“Controversies in Lung Cancer Screening:
Pro/Con Debate” is supported by educational
grants from AstraZeneca LP, Genentech, and
Pfizer Inc.
ATS PAR Forum Connects Patients, Experts
Sponsored by
7:00 pm
Implementation decisions are very important for determining that balance of benefit
and harm,” says Christopher Slatore, MD,
co-leader for the Lung Cancer Screening
Clinical Demonstration Project at the Veterans Affairs Portland Health Care System and
assistant professor of medicine at Oregon
Health & Science University.
Dr. Slatore is co-chair of the debate with
Anil Vachani, MD, MS, assistant professor of
medicine at the University of Pennsylvania
Perelman School of Medicine, Philadelphia,
and Nichole Tanner, MD, MSCR, assistant
professor of pulmonary, critical care, allergy,
and sleep medicine at the Medical University
of South Carolina, Charleston.
The speakers will discuss aspects of
screening where the balance of benefit and
harm may be altered, depending on how it is
implemented.
“The pro/con format is designed to highlight different balances of risk and harm, but
not provide simplistic answers for the right
or wrong ways to implement screening,” Dr.
Slatore says.
Presenters will provide pro and con
perspectives for whether or not lung cancer
screening should adhere to U.S. Preventive Services Task Force criteria, whether
Question & Answer
been transformed since the 2014 FDA approval of
pirfenidone and nintedanib for the treatment of
patients with IpF. Furthermore, clinical results from
the ASCEND, INpULSIS, and pANTHER trials have
raised many questions in the treatment of these
patients. providers considering these drugs for their
patients face decisions of which drug is best for an
individual patient, when to start, switch or combine
treatments, and how to manage side effects and
dosing. This case based symposium will explore
real-world issues of treating patients with IpF.
EDUCATIONAL ACTIVITY LEARNING OBJECTIVES
Upon completion of this course, the participants
should be able to:
• Describe the evidence using triple therapy or NAC
to treat IpF
• Discuss the efficacy, safety, and clinical application
of new treatment options for patients with IpF
COMMERCIAL SUPPORT ACKNOWLEDGMENT
This activity is supported by an educational grant
from Boehringer Ingelheim.
The France Foundation fully complies with the
legal requirements of the Americans with
Disabilities Act and the rules and regulations thereof.
There is no fee for this educational activity. Seating will be provided on a first-come, first-served basis.
S
aturday’s ATS Public Advisory
Roundtable (ATS PAR) gave patients
and family members the opportunity
to spend a half-day meeting with experts in
pulmonary, critical care, and sleep medicine,
and the popularity of the forum is catching
on. Attendance increased to 248 this year
from 190 at ATS 2014.
The Meet-the-Experts forum featured insightful talks on “Lungs and Environmental Health”
during the morning. Participants then met with
disease experts in breakout sessions focusing
on pulmonary hypertension, lipoarabinomannan/tuberous sclerosis, sarcoidois, scleroderma,
pulmonary fibrosis, rare lung diseases, children’s
interstitial lung disease, and Alpha-1.
The program resonated with Marj Korn, of
Arvado, CO, who was diagnosed with idiopathic pulmonary fibrosis in 2011. She says she
appreciated the awareness she gained about her
disease, current research, and how better to live
her life.
“Many other people really care and want to
find solutions to diseases that affect the lives of
others. I thought it was fabulous,” she says.
Now in their 30s, twins Candice and Crystal
Sipe were diagnosed with Hermansky-Pudlak
Sydrome when they were 13. Because they live
in Arizona where air quality is poor, Candice
says she was fascinated by the air quality presentations. Crystal says she appreciated the tips
to help her overcome her irregular sleep patterns. Both have attended the last four forums
and plan to attend ATS 2016 in San Francisco.
Meet-the-Expert Moderator Teresa Barnes
has lost five family members to pulmonary
fibrosis. Beyond giving patients the power to
improve their lives, the ATS PAR event gives
family members and caregivers a renewed
Experts met with patients and family members during
Saturday’s ATS PAR Forum.
understanding of what their family members
go through, says Ms. Barnes, past chair of ATS
PAR and vice president of the Coalition for
Pulmonary Fibrosis.
“A lot of times, there is a disconnect between
a patient and family member or a caregiver.
They understand the person has a disease, see
them day to day and know the realities of the
disease, but sometimes they don’t understand
why mom is always tired, why she sleeps more
than most people, why she sometimes is irritable, or why she gets anxious and pulls back
from the family,” Ms. Barnes says. “For them
to talk to experts and understand the reasons
people feel the way they do, I think they have
a renewed understanding of what their family
member is going through and a better relationship as a result.”
see PAR page 27
EXPERIENCE
OUR EXPANDING PORTFOLIO
VISIT BOOTH #160
Please read Brief Summary of full Prescribing Information for SYMBICORT, including Boxed WARNING on adjacent pages.
Please visit Booth 160 for full Prescribing Information.
SYMBICORT, PULMICORT FLEXHALER, and PRESSAIR are registered trademarks of the AstraZeneca group of companies. DALIRESP is a registered trademark of Takeda GmbH. TUDORZA is a registered trademark of ALMIRALL, S.A.
©2015 AstraZeneca. All rights reserved. 3117402 4/15
Trim 7.875 x 10.5
SYMBICORT ® 80/4.5
(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
SYMBICORT ® 160/4.5
(budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
For Oral Inhalation Only
Rx only
WARNING: ASTHMA RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in SYMBICORT,
increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety
of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an
increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class
effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent
use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related
death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related
hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, SYMBICORT
should only be used for patients not adequately controlled on a long-term asthma control medication, such as an
inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and
step down therapy (e.g., discontinue SYMBICORT) if possible without loss of asthma control and maintain the patient
on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients
whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [see WARNINGS AND
PRECAUTIONS].
BRIEF SUMMARY
Before prescribing, please see full Prescribing Information for SYMBICORT® (budesonide/formoterol fumarate dihydrate).
INDICATIONS AND USAGE
Treatment of Asthma
SYMBICORT is indicated for the treatment of asthma in patients 12 years of age and older.
Long-acting beta2-adrenergic agonists, such as formoterol one of the active ingredients in SYMBICORT, increase the risk of
asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related
hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS]. Therefore, when treating patients
with asthma, SYMBICORT should only be used for patients not adequately controlled on a long-term asthma-control
medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an
inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and
step down therapy (e.g. discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a
long-term asthma control medication, such as inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is
adequately controlled on low or medium dose inhaled corticosteroids.
Important Limitations of Use:
• SYMBICORT is NOT indicated for the relief of acute bronchospasm.
Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)
SYMBICORT 160/4.5 is indicated for the twice daily maintenance treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. SYMBICORT 160/4.5 is the only
approved dosage for the treatment of airflow obstruction in COPD.
Important Limitations of Use: SYMBICORT is not indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
SYMBICORT should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse
the mouth with water without swallowing [see PATIENT COUNSELING INFORMATION in full Prescribing Information (17.4)].
Prime SYMBICORT before using for the first time by releasing two test sprays into the air away from the face, shaking well for
5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped,
prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.
More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed
strength of SYMBICORT is not recommended as some patients are more likely to experience adverse effects with higher
doses of formoterol. Patients using SYMBICORT should not use additional long-acting beta2-agonists for any reason [see
WARNINGS AND PRECAUTIONS].
Asthma
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for
immediate relief.
Adult and Adolescent Patients 12 Years of Age and Older: For patients 12 years of age and older, the dosage is 2 inhalations
twice daily (morning and evening, approximately 12 hours apart).
The recommended starting dosages for SYMBICORT for patients 12 years of age and older are based upon patients’
asthma severity.
The maximum recommended dosage is SYMBICORT 160/4.5 mcg twice daily.
Improvement in asthma control following inhaled administration of SYMBICORT can occur within 15 minutes of beginning
treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients
will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with SYMBICORT 80/4.5,
replacement with SYMBICORT 160/4.5 may provide additional asthma control.
If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen
should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of SYMBICORT with the higher
strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.
Chronic Obstructive Pulmonary Disease (COPD)
For patients with COPD the recommended dose is SYMBICORT 160/4.5, two inhalations twice daily.
If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for
immediate relief.
CONTRAINDICATIONS
The use of SYMBICORT is contraindicated in the following conditions:
• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Hypersensitivity to any of the ingredients in SYMBICORT.
WARNINGS AND PRECAUTIONS
Asthma-Related Death
Long-acting beta2-adrenergic agonists, such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of
asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids
or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from
controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent
patients. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately
controlled on a long-term asthma-control medication, such as an inhaled corticosteroid or whose disease severity clearly
warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and
maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue SYMBICORT) if possible without
loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid.
Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
A 28-week, placebo controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma
therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with
salmeterol vs 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). This finding with salmeterol is
considered a class effect of the LABA, including formoterol, one of the active ingredients in SYMBICORT. No study adequate
to determine whether the rate of asthma-related death is increased with SYMBICORT has been conducted.
Clinical studies with formoterol suggested a higher incidence of serious asthma exacerbations in patients who received
formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the
differences in serious asthma exacerbation rates between treatment groups.
Deterioration of Disease and Acute Episodes
SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma
or COPD. SYMBICORT has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of
SYMBICORT in this setting is not appropriate.
Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. In this situation, the patient
requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible
need for replacing the current strength of SYMBICORT with a higher strength, adding additional inhaled corticosteroid,
or initiating systemic corticosteroids. Patients should not use more than 2 inhalations twice daily (morning and evening)
of SYMBICORT.
SYMBICORT should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes
of bronchospasm. An inhaled, short-acting beta2-agonist, not SYMBICORT, should be used to relieve acute symptoms
such as shortness of breath. When prescribing SYMBICORT, the physician must also provide the patient with an inhaled,
short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and
evening) use of SYMBICORT.
When beginning treatment with SYMBICORT, patients who have been taking oral or inhaled, short-acting beta2-agonists on
a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Excessive Use of SYMBICORT and Use with Other Long-Acting Beta2-Agonists
As with other inhaled drugs containing beta2-adrenergic agents, SYMBICORT should not be used more often than
recommended, at higher doses than recommended, or in conjunction with other medications containing long-acting
beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs. Patients using SYMBICORT should not use an additional
long-acting beta2-agonist (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention
of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD.
Local Effects
In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in
patients treated with SYMBICORT. When such an infection develops, it should be treated with appropriate local or systemic
(i.e., oral antifungal) therapy while treatment with SYMBICORT continues, but at times therapy with SYMBICORT may need to
be interrupted. Patients should rinse the mouth after inhalation of SYMBICORT.
Pneumonia and Other Lower Respiratory Tract Infections
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features
of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been
reported following the inhaled administration of corticosteroids.
In a 6 month study of 1,704 patients with COPD, there was a higher incidence of lung infections other than pneumonia (e.g.,
bronchitis, viral lower respiratory tract infections, etc.) in patients receiving SYMBICORT 160/4.5 (7.6%) than in those
receiving SYMBICORT 80/4.5 (3.2%), formoterol 4.5 mcg (4.6%) or placebo (3.3%). Pneumonia did not occur with greater
incidence in the SYMBICORT 160/4.5 group (1.1 %) compared with placebo (1.3%). In a 12-month study of 1,964 patients
with COPD, there was also a higher incidence of lung infections other than pneumonia in patients receiving SYMBICORT
160/4.5 (8.1%) than in those receiving SYMBICORT 80/4.5 (6.9%), formoterol 4.5 mcg (7.1%) or placebo (6.2%). Similar to
the 6 month study, pneumonia did not occur with greater incidence in the SYMBICORT 160/4.5 group (4.0%) compared with
placebo (5.0%).
Immunosuppression
Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals.
Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using
corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care
should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of
developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid
treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous
immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular
immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing
information.) If chicken pox develops, treatment with antiviral agents may be considered. The immune responsiveness
to varicella vaccine was evaluated in pediatric patients with asthma ages 12 months to 8 years with budesonide
inhalation suspension.
An open-label, nonrandomized clinical study examined the immune responsiveness to varicella vaccine in 243 asthma
patients 12 months to 8 years of age who were treated with budesonide inhalation suspension 0.25 mg to 1 mg daily (n=151)
or noncorticosteroid asthma therapy (n=92) (i.e., beta2-agonists, leukotriene receptor antagonists, cromones).
The percentage of patients developing a seroprotective antibody titer of ≥5.0 (gpELISA value) in response to the vaccination
was similar in patients treated with budesonide inhalation suspension (85%), compared to patients treated with noncorticosteroid asthma therapy (90%). No patient treated with budesonide inhalation suspension developed chicken pox as a result
of vaccination.
Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the
respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Transferring Patients From Systemic Corticosteroid Therapy
Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from
systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.
Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most
susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of
HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or
infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although SYMBICORT
may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal
physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary
for coping with these emergencies.
During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should
be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further
instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary
systemic corticosteroids during periods of stress or a severe asthma attack.
Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to
SYMBICORT. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis
during therapy with SYMBICORT. Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak
expiratory flow [PEF], beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral
corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms
of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.
Transfer of patients from systemic corticosteroid therapy to inhaled corticosteroids or SYMBICORT may unmask conditions
previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic
conditions). Some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or
muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function.
Hypercorticism and Adrenal Suppression
Budesonide, a component of SYMBICORT, will often help control asthma symptoms with less suppression of HPA function
than therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the circulation and can be
systemically active at higher doses, the beneficial effects of SYMBICORT in minimizing HPA dysfunction may be expected only
when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.
Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with SYMBICORT should be
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observed carefully for any evidence of systemic c
postoperatively or during periods of stress for ev
It is possible that systemic corticosteroid effects
may appear in a small number of patients, particu
over prolonged periods of time. If such effects o
accepted procedures for reducing systemic cortic
Drug Interactions With Strong Cytoch
Caution should be exercised when considering
strong CYP3A4 inhibitors (e.g., ritonavir, atazanav
telithromycin) because adverse effects related
INTERACTIONS and CLINICAL PHARMACOLOGY
Paradoxical Bronchospasm and Upp
As with other inhaled medications, SYMBICORT
If paradoxical bronchospasm occurs following d
short-acting bronchodilator, SYMBICORT should
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur
angioedema, rash, and bronchospasm.
Cardiovascular and Central Nervous
Excessive beta-adrenergic stimulation has been a
with rates up to 200 beats/min, arrhythmias, nerv
and insomnia [see OVERDOSAGE]. Therefore, S
be used with caution in patients with cardiova
and hypertension.
Formoterol, a component of SYMBICORT, can
measured by pulse rate, blood pressure, and/or
formoterol at recommended doses, if they occur,
reported to produce ECG changes, such as flat
depression. The clinical significance of these find
use of inhaled sympathomimetic drugs.
Reduction in Bone Mineral Density
Decreases in bone mineral density (BMD) have b
corticosteroids. The clinical significance of small
unknown. Patients with major risk factors for d
history of osteoporosis, post menopausal status,
reduce bone mass (e.g., anticonvulsants, oral cor
care. Since patients with COPD often have multip
to initiating SYMBICORT and periodically there
considered medically important for that patient’s
strongly considered.
Effects of treatment with SYMBICORT 160/4.5, S
subset of 326 patients (females and males 41 to
hip and lumbar spine regions were conducted a
scans. Mean changes in BMD from baseline to en
ANCOVA results for total spine and total hip BMD
ratios for the pairwise treatment group compariso
and total spine regions for the 12 month time poi
Effect on Growth
Orally inhaled corticosteroids may cause a reduc
growth of pediatric patients receiving SYMBICOR
inhaled corticosteroids, including SYMBICORT, tit
symptoms [see DOSAGE AND ADMINISTRATION
Glaucoma and Cataracts
Glaucoma, increased intraocular pressure, and c
the long-term administration of inhaled cortico
close monitoring is warranted in patients with a c
and/or cataracts.
Effects of treatment with SYMBICORT 160/4.5
cataracts or glaucoma were evaluated in a subset
were conducted at baseline, 24 weeks, and 52 we
score from baseline to maximum value (>0.7) d
scores of >0.7 from baseline to treatment max
4 patients (3.8%) in the SYMBICORT 80/4.5 grou
placebo group.
Eosinophilic Conditions and Churg-St
In rare cases, patients on inhaled corticosteroids
have clinical features of vasculitis consistent wit
corticosteroid therapy. These events usually, but
oral corticosteroid therapy following the introduc
vasculitic rash, worsening pulmonary symptom
A causal relationship between budesonide and th
Coexisting Conditions
SYMBICORT, like all medications containing s
convulsive disorders or thyrotoxicosis and in tho
related beta2-adrenoceptor agonist albuterol, whe
diabetes mellitus and ketoacidosis.
Hypokalemia and Hyperglycemia
Beta-adrenergic agonist medications may produ
shunting, which has the potential to produce
Prescribing Information (12.2)]. The decrease
Clinically significant changes in blood glucose a
SYMBICORT at recommended doses.
ADVERSE REACTIONS
Long-acting beta2-adrenergic agonists, such as
of asthma-related death. Currently available da
steroids or other long-term asthma control dr
Available data from controlled clinical trials s
pediatric and adolescent patients. Data from a l
acting beta2-adrenergic agonist (salmeterol) or pl
deaths in patients receiving salmeterol [see WAR
Systemic and inhaled corticosteroid use may resu
- Candida albicans infection [see WARNINGS A
- Pneumonia or lower respiratory tract infection
- Immunosuppression [see WARNINGS AND P
- Hypercorticism and adrenal suppression [see
- Growth effects in pediatric patients [see WARN
- Glaucoma and cataracts [see WARNINGS AND
Because clinical trials are conducted under wide
of a drug cannot be directly compared to rates i
in practice.
ol with placebo, each added to usual asthma
salmeterol (13/13,176 in patients treated with
1.25, 15.34). This finding with salmeterol is
ingredients in SYMBICORT. No study adequate
BICORT has been conducted.
sthma exacerbations in patients who received
s were not adequate to precisely quantify the
potentially life-threatening episodes of asthma
eriorating asthma or COPD. The initiation of
riorating asthma. In this situation, the patient
en, giving special consideration to the possible
ngth, adding additional inhaled corticosteroid,
inhalations twice daily (morning and evening)
cue therapy for the treatment of acute episodes
T, should be used to relieve acute symptoms
must also provide the patient with an inhaled,
ms, despite regular twice-daily (morning and
oral or inhaled, short-acting beta2-agonists on
egular use of these drugs.
cting Beta2-Agonists
CORT should not be used more often than
with other medications containing long-acting
ular effects and fatalities have been reported in
using SYMBICORT should not use an additional
ol tartrate) for any reason, including prevention
D.
pharynx with Candida albicans has occurred in
d be treated with appropriate local or systemic
at times therapy with SYMBICORT may need to
RT.
a in patients with COPD as the clinical features
ct infections, including pneumonia, have been
e of lung infections other than pneumonia (e.g.,
ng SYMBICORT 160/4.5 (7.6%) than in those
(3.3%). Pneumonia did not occur with greater
(1.3%). In a 12-month study of 1,964 patients
pneumonia in patients receiving SYMBICORT
ol 4.5 mcg (7.1%) or placebo (6.2%). Similar to
MBICORT 160/4.5 group (4.0%) compared with
sceptible to infection than healthy individuals.
l course in susceptible children or adults using
s or been properly immunized, particular care
orticosteroid administration affects the risk of
underlying disease and/or prior corticosteroid
r immune globulin (VZIG) or pooled intravenous
easles, prophylaxis with pooled intramuscular
serts for complete VZIG and IG prescribing
y be considered. The immune responsiveness
ges 12 months to 8 years with budesonide
nsiveness to varicella vaccine in 243 asthma
ation suspension 0.25 mg to 1 mg daily (n=151)
ukotriene receptor antagonists, cromones).
(gpELISA value) in response to the vaccination
, compared to patients treated with noncorticosuspension developed chicken pox as a result
ctive or quiescent tuberculosis infections of the
ions; or ocular herpes simplex.
y
mically active corticosteroids to inhaled corticonts with asthma during and after transfer from
oids. After withdrawal from systemic corticotary-adrenal (HPA) function.
of prednisone (or its equivalent) may be most
st completely withdrawn. During this period of
fficiency when exposed to trauma, surgery, or
severe electrolyte loss. Although SYMBICORT
mmended doses it supplies less than normal
the mineralocorticoid activity that is necessary
withdrawn from systemic corticosteroids should
y and to contact their physicians for further
d indicating that they may need supplementary
stemic corticosteroid use after transferring to
y prednisone dose by 2.5 mg on a weekly basis
volume in 1 second [FEV1] or morning peak
carefully monitored during withdrawal of oral
nts should be observed for signs and symptoms
miting, and hypotension.
eroids or SYMBICORT may unmask conditions
, conjunctivitis, eczema, arthritis, eosinophilic
ve corticosteroid withdrawal (e.g., joint and/or
ment of respiratory function.
mptoms with less suppression of HPA function
e is absorbed into the circulation and can be
nimizing HPA dysfunction may be expected only
ated to the lowest effective dose.
, patients treated with SYMBICORT should be
Trim 7.875 x 10.5
SYMBICORT ® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients
postoperatively or during periods of stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis)
may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses
over prolonged periods of time. If such effects occur, the dosage of SYMBICORT should be reduced slowly, consistent with
accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.
Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
Caution should be exercised when considering the coadministration of SYMBICORT with ketoconazole, and other known
strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir,
telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur [see DRUG
INTERACTIONS and CLINICAL PHARMACOLOGY in full Prescribing Information (12.3)].
Paradoxical Bronchospasm and Upper Airway Symptoms
As with other inhaled medications, SYMBICORT can produce paradoxical bronchospasm, which may be life threatening.
If paradoxical bronchospasm occurs following dosing with SYMBICORT, it should be treated immediately with an inhaled,
short-acting bronchodilator, SYMBICORT should be discontinued immediately, and alternative therapy should be instituted.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of SYMBICORT, as demonstrated by cases of urticaria,
angioedema, rash, and bronchospasm.
Cardiovascular and Central Nervous System Effects
Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia
with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise,
and insomnia [see OVERDOSAGE]. Therefore, SYMBICORT, like all products containing sympathomimetic amines, should
be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias,
and hypertension.
Formoterol, a component of SYMBICORT, can produce a clinically significant cardiovascular effect in some patients as
measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of
formoterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been
reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment
depression. The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive
use of inhaled sympathomimetic drugs.
Reduction in Bone Mineral Density
Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled
corticosteroids. The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is
unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family
history of osteoporosis, post menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can
reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of
care. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior
to initiating SYMBICORT and periodically thereafter. If significant reductions in BMD are seen and SYMBICORT is still
considered medically important for that patient’s COPD therapy, use of medication to treat or prevent osteoporosis should be
strongly considered.
Effects of treatment with SYMBICORT 160/4.5, SYMBICORT 80/4.5, formoterol 4.5, or placebo on BMD was evaluated in a
subset of 326 patients (females and males 41 to 88 years of age) with COPD in the 12-month study. BMD evaluations of the
hip and lumbar spine regions were conducted at baseline and 52 weeks using dual energy x-ray absorptiometry (DEXA)
scans. Mean changes in BMD from baseline to end of treatment were small (mean changes ranged from -0.01 - 0.01 g/cm2).
ANCOVA results for total spine and total hip BMD based on the end of treatment time point showed that all geometric LS Mean
ratios for the pairwise treatment group comparisons were close to 1, indicating that overall, bone mineral density for total hip
and total spine regions for the 12 month time point were stable over the entire treatment period.
Effect on Growth
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the
growth of pediatric patients receiving SYMBICORT routinely (e.g., via stadiometry). To minimize the systemic effects of orally
inhaled corticosteroids, including SYMBICORT, titrate each patient’s dose to the lowest dosage that effectively controls his/her
symptoms [see DOSAGE AND ADMINISTRATION and USE IN SPECIFIC POPULATIONS].
Glaucoma and Cataracts
Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following
the long-term administration of inhaled corticosteroids, including budesonide, a component of SYMBICORT. Therefore,
close monitoring is warranted in patients with a change in vision or with history of increased intraocular pressure, glaucoma,
and/or cataracts.
Effects of treatment with SYMBICORT 160/4.5, SYMBICORT 80/4.5, formoterol 4.5, or placebo on development of
cataracts or glaucoma were evaluated in a subset of 461 patients with COPD in the 12-month study. Ophthalmic examinations
were conducted at baseline, 24 weeks, and 52 weeks. There were 26 subjects (6%) with an increase in posterior subcapsular
score from baseline to maximum value (>0.7) during the randomized treatment period. Changes in posterior subcapsular
scores of >0.7 from baseline to treatment maximum occurred in 11 patients (9.0%) in the SYMBICORT 160/4.5 group,
4 patients (3.8%) in the SYMBICORT 80/4.5 group, 5 patients (4.2%) in the formoterol group, and 6 patients (5.2%) in the
placebo group.
Eosinophilic Conditions and Churg-Strauss Syndrome
In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients
have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic
corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of
oral corticosteroid therapy following the introduction of inhaled corticosteroids. Physicians should be alert to eosinophilia,
vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
A causal relationship between budesonide and these underlying conditions has not been established.
Coexisting Conditions
SYMBICORT, like all medications containing sympathomimetic amines, should be used with caution in patients with
convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the
related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting
diabetes mellitus and ketoacidosis.
Hypokalemia and Hyperglycemia
Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular
shunting, which has the potential to produce adverse cardiovascular effects [see CLINICAL PHARMACOLOGY in full
Prescribing Information (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation.
Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with
SYMBICORT at recommended doses.
ADVERSE REACTIONS
Long-acting beta2-adrenergic agonists, such as formoterol one of the active ingredients in SYMBICORT, increase the risk
of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in
pediatric and adolescent patients. Data from a large placebo-controlled US study that compared the safety of another longacting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related
deaths in patients receiving salmeterol [see WARNINGS AND PRECAUTIONS].
Systemic and inhaled corticosteroid use may result in the following:
- Candida albicans infection [see WARNINGS AND PRECAUTIONS]
- Pneumonia or lower respiratory tract infections in patients with COPD [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
- Growth effects in pediatric patients [see WARNINGS AND PRECAUTIONS]
- Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials
of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed
in practice.
2
Clinical Trials Experience in Asthma
Patients 12 years and older
The overall safety data in adults and adolescents are based upon 10 active- and placebo-controlled clinical trials in which
3393 patients ages 12 years and older (2052 females and 1341 males) with asthma of varying severity were treated with
SYMBICORT 80/4.5 or 160/4.5 mcg taken two inhalations once or twice daily for 12 to 52 weeks. In these trials, the patients
on SYMBICORT had a mean age of 38 years and were predominantly Caucasian (82%).
The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind,
placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and
older were treated with two inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5 twice daily. The SYMBICORT group
was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV1 at
baseline of 76 and 68 for the 80/4.5 mcg and 160/4.5 mcg treatment groups, respectively. Control arms for comparison
included two inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI)
4.5 mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of ≥3% in
any one SYMBICORT group and more commonly than in the placebo group with twice-daily dosing. In considering these data,
the increased average duration of patient exposure for SYMBICORT patients should be taken into account, as incidences are
not adjusted for an imbalance of treatment duration.
Table 1 Adverse reactions occurring at an incidence of ≥3% and more commonly than placebo in the SYMBICORT
groups: pooled data from three 12-week, double-blind, placebo-controlled clinical asthma trials in patients
12 years and older
Treatment*
Adverse Event
Nasopharyngitis
Headache
Upper respiratory
tract infection
Pharyngolaryngeal pain
Sinusitis
Influenza
Back pain
Nasal congestion
Stomach discomfort
Vomiting
Oral Candidiasis
Average Duration of
Exposure (days)
SYMBICORT
80/4.5 mcg 160/4.5 mcg
N = 277
N =124
%
%
10.5
9.7
6.5
11.3
Budesonide
80 mcg
160 mcg
N =121
N = 109
%
%
14.0
11.0
11.6
12.8
Formoterol
4.5 mcg
N = 237
%
10.1
8.9
Placebo
N = 400
%
9.0
6.5
7.6
6.1
5.8
3.2
3.2
2.5
1.1
1.4
1.4
10.5
8.9
4.8
2.4
1.6
3.2
6.5
3.2
3.2
8.3
5.0
5.8
6.6
2.5
2.5
2.5
0.8
0
9.2
7.3
2.8
0.9
5.5
3.7
4.6
2.8
0
7.6
3.0
6.3
3.0
2.1
1.3
1.3
1.7
0
7.8
4.8
4.8
1.3
0.8
1.0
1.8
1.0
0.8
77.7
73.8
77.0
71.4
62.4
55.9
* All treatments were administered as two inhalations twice daily.
Long-term safety - asthma clinical trials in patients 12 years and older
Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to 1 year at doses up to
1280/36 mcg/day (640/18 mcg twice daily), revealed neither clinically important changes in the incidence nor new types of
adverse events emerging after longer periods of treatment. Similarly, no significant or unexpected patterns of abnormalities
were observed for up to 1 year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis
assessments.
Clinical Trials Experience in Chronic Obstructive Pulmonary Disease
The incidence of common adverse events in Table 2 below is based upon pooled data from two double-blind, placebocontrolled clinical studies (6 and 12 months in duration) in which 771 adult COPD patients (496 males and 275 females)
40 years of age and older were treated with SYMBICORT 160/4.5, two inhalations twice daily. Of these patients 651 were
treated for 6 months and 366 were treated for 12 months. The SYMBICORT group was composed of mostly Caucasian (93%)
patients with a mean age of 63 years, and a mean percent predicted FEV1 at baseline of 33%. Control arms for comparison
included two inhalations of budesonide HFA (MDI) 160 mcg, formoterol (DPI) 4.5 mcg or placebo (MDI and DPI) twice daily.
Table 2 includes all adverse events that occurred at an incidence of ≥3% in the SYMBICORT group and more commonly than
in the placebo group. In considering these data, the increased average duration of patient exposure to SYMBICORT should be
taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Table 2 Adverse reactions occurring at an incidence of ≥3% and more commonly than placebo in the
SYMBICORT group: pooled data from two double-blind, placebo-controlled clinical COPD trials
Treatment*
Adverse Event
Nasopharyngitis
Oral candidiasis
Bronchitis
Sinusitis
Upper respiratory tract
infection viral
Average Duration of
Exposure (days)
SYMBICORT
160/4.5 mcg
N = 771
%
7.3
6.0
5.4
3.5
Budesonide
160 mcg
N = 275
%
3.3
4.4
4.7
1.5
Formoterol
4.5 mcg
N = 779
%
5.8
1.2
4.5
3.1
Placebo
3.5
1.8
3.6
2.7
255.2
157.1
240.3
223.7
N = 781
%
4.9
1.8
3.5
1.8
* All treatments were administered as two inhalations twice daily.
Lung infections other than pneumonia (mostly bronchitis) occurred in a greater percentage of subjects treated with
SYMBICORT 160/4.5 compared with placebo (7.9% vs. 5.1%, respectively). There were no clinically important or unexpected
patterns of abnormalities observed for up to 1 year in chemistry, haematology, ECG, ECG (Holter) monitoring, HPA-axis, bone
mineral density and ophthalmology assessments.
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of SYMBICORT. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical
studies with SYMBICORT.
Cardiac disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles,
palpitations
Endocrine disorders: hypercorticism, growth velocity reduction in pediatric patients
Eye disorders: cataract, glaucoma, increased intraocular pressure
Gastrointestinal disorders: oropharyngeal candidiasis, nausea
Immune system disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema,
bronchospasm, urticaria, exanthema, dermatitis, pruritus
Metabolic and nutrition disorders: hyperglycemia, hypokalemia
Musculoskeletal, connective tissue, and bone disorders: muscle cramps
Nervous system disorders: tremor, dizziness
Psychiatric disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness
Respiratory, thoracic, and mediastinal disorders: dysphonia, cough, throat irritation
Skin and subcutaneous tissue disorders: skin bruising
Vascular disorders: hypotension, hypertension
DRUG INTERACTIONS
In clinical studies, concurrent administration of SYMBICORT and other drugs, such as short-acting beta2-agonists, intranasal
corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal
drug interaction studies have been performed with SYMBICORT.
083-42487
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Trim 7.875 x 10.5
SYMBICORT ® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
Inhibitors of Cytochrome P450 3A4
The main route of metabolism of corticosteroids, including budesonide, a component of SYMBICORT, is via cytochrome
P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean
plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit
the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering
the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g.,
ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see WARNINGS
AND PRECAUTIONS].
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
SYMBICORT should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic
antidepressants, or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of
SYMBICORT, on the vascular system may be potentiated by these agents. In clinical trials with SYMBICORT, a limited number
of COPD and asthma patients received tricyclic antidepressants, and, therefore, no clinically meaningful conclusions on
adverse events can be made.
Beta-Adrenergic Receptor Blocking Agents
Beta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as formoterol,
a component of SYMBICORT, but may produce severe bronchospasm in patients with asthma. Therefore, patients
with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no
acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective
beta-blockers could be considered, although they should be administered with caution.
Diuretics
The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such
as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the
beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the
coadministration of SYMBICORT with non–potassium-sparing diuretics.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects: Pregnancy Category C.
There are no adequate and well-controlled studies of SYMBICORT in pregnant women. SYMBICORT was teratogenic and
embryocidal in rats. Budesonide alone was teratogenic and embryocidal in rats and rabbits, but not in humans at therapeutic
doses. Formoterol fumarate alone was teratogenic in rats and rabbits. Formoterol fumarate was also embryocidal, increased
pup loss at birth and during lactation, and decreased pup weight in rats. SYMBICORT should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus.
SYMBICORT
In a reproduction study in rats, budesonide combined with formoterol fumarate by the inhalation route at doses approximately
1/7 and 1/3, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis produced umbilical
hernia. No teratogenic or embryocidal effects were detected with budesonide combined with formoterol fumarate by the
inhalation route at doses approximately 1/32 and 1/16, respectively, the maximum recommended human daily inhalation dose
on a mg/m2 basis.
Budesonide
Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered
during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from
three Swedish registries covering approximately 99% of the pregnancies from 1995-1997 (ie, Swedish Medical
Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital
malformations from the use of inhaled budesonide during early pregnancy. Congenital malformations were studied in
2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10-12 weeks
after the last menstrual period), the period when most major organ malformations occur. The rate of recorded congenital
malformations was similar compared to the general population rate (3.8% vs 3.5%, respectively). In addition, after exposure
to inhaled budesonide, the number of infants born with orofacial clefts was similar to the expected number in the normal
population (4 children vs 3.3, respectively).
These same data were utilized in a second study bringing the total to 2534 infants whose mothers were exposed to inhaled
budesonide. In this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%).
Budesonide produced fetal loss, decreased pup weight, and skeletal abnormalities at subcutaneous doses in rabbits less than
the maximum recommended human daily inhalation dose on a mcg/m2 basis and in rats at doses approximately 6 times
the maximum recommended human daily inhalation dose on a mcg/m2 basis. In another study in rats, no teratogenic or
embryocidal effects were seen at inhalation doses up to 3 times the maximum recommended human daily inhalation dose on
a mcg/m2 basis.
Experience with oral corticosteroids since their introduction in pharmacologic as opposed to physiologic doses suggests that
rodents are more prone to teratogenic effects from corticosteroids than humans.
Formoterol
Formoterol fumarate has been shown to be teratogenic, embryocidal, to increase pup loss at birth and during lactation, and
to decrease pup weights in rats when given at oral doses 1400 times and greater the maximum recommended human daily
inhalation dose on a mcg/m2 basis. Umbilical hernia was observed in rat fetuses at oral doses 1400 times and greater the
maximum recommended human daily inhalation dose on a mcg/m2 basis. Brachygnathia was observed in rat fetuses at an
oral dose 7000 times the maximum recommended human daily inhalation dose on a mcg/m2 basis. Pregnancy was prolonged
at an oral dose 7000 times the maximum recommended human daily inhalation dose on a mcg/m2 basis. In another study in
rats, no teratogenic effects were seen at inhalation doses up to 500 times the maximum recommended human daily inhalation
dose on a mcg/m2 basis.
Subcapsular cysts on the liver were observed in rabbit fetuses at an oral dose 54,000 times the maximum recommended
human daily inhalation dose on a mcg/m2 basis. No teratogenic effects were observed at oral doses up to 3200 times the
maximum recommended human daily inhalation dose on a mcg/m2 basis.
Nonteratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be
carefully observed.
Labor and Delivery
There are no well-controlled human studies that have investigated the effects of SYMBICORT on preterm labor or labor at
term. Because of the potential for beta-agonist interference with uterine contractility, use of SYMBICORT for management of
asthma during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.
Nursing Mothers
Since there are no data from controlled trials on the use of SYMBICORT by nursing mothers, a decision should be made whether
to discontinue nursing or to discontinue SYMBICORT, taking into account the importance of SYMBICORT to the mother.
Budesonide, like other corticosteroids, is secreted in human milk. Data with budesonide delivered via dry powder inhaler
indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of
the dose inhaled by the mother [see CLINICAL PHARMACOLOGY, Pharmacokinetics in full Prescribing Information (12.3)].
For SYMBICORT, the dose of budesonide available to the infant in breast milk, as a percentage of the maternal dose, would be
expected to be similar.
In reproductive studies in rats, formoterol was excreted in the milk. It is not known whether formoterol is excreted in
human milk.
Pediatric Use
Safety and effectiveness of SYMBICORT in asthma patients 12 years of age and older have been established in studies up
to 12 months. In the two 12-week, double-blind, placebo-controlled US pivotal studies 25 patients 12 to 17 years of age were
treated with SYMBICORT twice daily [see CLINICAL STUDIES in full Prescribing Information (14.1)]. Efficacy results in this
age group were similar to those observed in patients 18 years and older. There were no obvious differences in the type
or frequency of adverse events reported in this age group compared with patients 18 years of age and older.
The safety and effectiveness of SYMBICORT in asthma patients 6 to <12 years of age has not been established.
Overall 1447 asthma patients 6 to <12 years of age participated in placebo- and active-controlled SYMBICORT studies.
Of these 1447 patients, 539 received SYMBICORT twice daily. The overall safety profile of these patients was similar to that
observed in patients ≥12 years of age who also received SYMBICORT twice daily in studies of similar design.
3
Controlled clinical studies have shown that orally inhaled corticosteroids including budesonide, a component of SYMBICORT,
may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory
evidence of HPA-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid
exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effect of this reduction in
growth velocity associated with orally inhaled corticosteroids, including the impact on final height are unknown. The potential
for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately
studied.
In a study of asthmatic children 5-12 years of age, those treated with budesonide DPI 200 mcg twice daily (n=311) had a
1.1 centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference
between these two treatment groups did not increase further over three years of additional treatment. By the end of 4 years,
children treated with budesonide DPI and children treated with placebo had similar growth velocities. Conclusions drawn from
this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from
patients attaining puberty during the course of the study.
The growth of pediatric patients receiving orally inhaled corticosteroids, including SYMBICORT, should be monitored. If a
child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly
sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against the
clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including SYMBICORT, each patient
should be titrated to the lowest strength that effectively controls his/her asthma [see DOSAGE AND ADMINISTRATION].
Geriatric Use
Of the total number of patients in asthma clinical studies treated with SYMBICORT twice daily, 149 were 65 years of age
or older, of whom 25 were 75 years of age or older.
In the COPD studies of 6 to 12 months duration, 349 patients treated with SYMBICORT 160/4.5 twice daily were 65 years old
and above and of those, 73 patients were 75 years of age and older. No overall differences in safety or effectiveness were
observed between these patients and younger patients, and other reported clinical experience has not identified differences
in responses between the elderly and younger patients.
As with other products containing beta2-agonists, special caution should be observed when using SYMBICORT in geriatric
patients who have concomitant cardiovascular disease that could be adversely affected by beta2-agonists.
Based on available data for SYMBICORT or its active components, no adjustment of dosage of SYMBICORT in geriatric
patients is warranted.
Hepatic Impairment
Formal pharmacokinetic studies using SYMBICORT have not been conducted in patients with hepatic impairment. However,
since both budesonide and formoterol fumarate are predominantly cleared by hepatic metabolism, impairment of liver
function may lead to accumulation of budesonide and formoterol fumarate in plasma. Therefore, patients with hepatic disease
should be closely monitored.
Renal Impairment
Formal pharmacokinetic studies using SYMBICORT have not been conducted in patients with renal impairment.
OVERDOSAGE
SYMBICORT
SYMBICORT contains both budesonide and formoterol; therefore, the risks associated with overdosage for the individual
components described below apply to SYMBICORT. In pharmacokinetic studies, single doses of 960/54 mcg (12 actuations
of SYMBICORT 80/4.5) and 1280/36 mcg (8 actuations of 160/4.5), were administered to patients with COPD. A total of
1920/54 mcg (12 actuations of SYMBICORT 160/4.5) was administered as a single dose to both healthy subjects and patients
with asthma. In a long-term active-controlled safety study in asthma patients, SYMBICORT 160/4.5 was administered for up
to 12 months at doses up to twice the highest recommended daily dose. There were no clinically significant adverse reactions
observed in any of these studies.
Clinical signs in dogs that received a single inhalation dose of SYMBICORT (a combination of budesonide and formoterol) in
a dry powder included tremor, mucosal redness, nasal catarrh, redness of intact skin, abdominal respiration, vomiting, and
salivation; in the rat, the only clinical sign observed was increased respiratory rate in the first hour after dosing. No deaths
occurred in rats given a combination of budesonide and formoterol at acute inhalation doses of 97 and 3 mg/kg, respectively
(approximately 1200 and 1350 times the maximum recommended human daily inhalation dose on a mcg/m2 basis).
No deaths occurred in dogs given a combination of budesonide and formoterol at the acute inhalation doses of 732 and
22 mcg/kg, respectively (approximately 30 times the maximum recommended human daily inhalation dose of budesonide and
formoterol on a mcg/m2 basis).
Budesonide
The potential for acute toxic effects following overdose of budesonide is low. If used at excessive doses for prolonged periods,
systemic corticosteroid effects such as hypercorticism may occur [see WARNINGS AND PRECAUTIONS]. Budesonide at five
times the highest recommended dose (3200 mcg daily) administered to humans for 6 weeks caused a significant reduction
(27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%). The corresponding effect
of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH.
In mice, the minimal inhalation lethal dose was 100 mg/kg (approximately 600 times the maximum recommended human
daily inhalation dose on a mcg/m2 basis). In rats, there were no deaths following the administration of an inhalation dose of
68 mg/kg (approximately 900 times the maximum recommended human daily inhalation dose on a mcg/m2 basis). The
minimal oral lethal dose in mice was 200 mg/kg (approximately 1300 times the maximum recommended human daily
inhalation dose on a mcg/m2 basis) and less than 100 mg/kg in rats (approximately 1300 times the maximum recommended
human daily inhalation dose on a mcg/m2 basis).
Formoterol
An overdose of formoterol would likely lead to an exaggeration of effects that are typical for beta2-agonists: seizures,
angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor,
palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with
all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of formoterol. No clinically
significant adverse reactions were seen when formoterol was delivered to adult patients with acute bronchoconstriction at
a dose of 90 mcg/day over 3 hours or to stable asthmatics 3 times a day at a total dose of 54 mcg/day for 3 days.
Treatment of formoterol overdosage consists of discontinuation of the medication together with institution of appropriate
symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered,
bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis
is beneficial for overdosage of formoterol. Cardiac monitoring is recommended in cases of overdosage.
No deaths were seen in mice given formoterol at an inhalation dose of 276 mg/kg (more than 62,200 times the maximum
recommended human daily inhalation dose on a mcg/m2 basis). In rats, the minimum lethal inhalation dose was 40 mg/kg
(approximately 18,000 times the maximum recommended human daily inhalation dose on a mcg/m2 basis). No deaths
were seen in mice that received an oral dose of 2000 mg/kg (more than 450,000 times the maximum recommended human
daily inhalation dose on a mcg/m2 basis). Maximum nonlethal oral doses were 252 mg/kg in young rats and 1500 mg/kg
in adult rats (approximately 114,000 times and 675,000 times the maximum recommended human inhalation dose on
a mcg/m2 basis).
SYMBICORT is a trademark of the AstraZeneca group of companies.
© AstraZeneca 2008, 2009, 2010, 2012
Manufactured for: AstraZeneca LP, Wilmington, DE 19850
By: AstraZeneca Dunkerque Production, Dunkerque, France
Product of France
Rev. 5/12 2839500 8/13
083-42487
Page 4
BW
Job Number: 21264
Revision No: 0
Date: 5/1/15
13
ATS Foundation Thanks 2014 Contributors for Their Support
T
he ATS is pleased to recognize its
generous donors who contributed to
the Foundation’s Funds for the Future
Annual Campaign from Jan. 1, 2014, to Dec.
31, 2014.
RESEARCH PROGRAM PARTNERS*
$80,000 OR MORE
• Pulmonary Hypertension Association
$60,000–$99,999
• Scleroderma Foundation
$30,000–$59,999
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Alpha-1 Foundation
Breathe California of Los Angeles County
chILD Foundation
Coalition for Pulmonary Fibrosis
Hermansky-Pudlak Syndrome Network
Pulmonary Fibrosis Foundation
$10,000–$29,999
• Alliance for Academic Internal Medicine/The
Association of Specialty Professions
• American Lung Association
* Dollars represent the total amount pledged for new and
ongoing 2014 awards
SIXTH ANNUAL RESEARCH PROGRAM
BENEFIT CORPORATE SUPPORTERS
$60,000 PLATINUM SUPPORTER
• Boehringer Ingelheim Pharmaceuticals, Inc.
$25,000 GOLD LEVEL
SUPPORTERS
• AstraZeneca LP
• Genentech/Novartis
• Sunovion Pharmaceuticals, Inc.
$10,000 SILVER LEVEL
SUPPORTER
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Forest Laboratories, Inc.
Gilead Sciences, Inc.
InterMune, Inc.
Teva Respiratory
$5,000 BRONZE LEVEL
SUPPORTERS
• Bayer HealthCare
• MEDA Pharmaceuticals
THE EDWARD LIVINGSTON
TRUDEAU SOCIETY**
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William C. Bailey, MD
Sonia Buist, MD
David W. Cugell, MD
James F. Donohue, MD
Oscar H. Friedman, MD†
Robert B. Mellins, MD†
Sharon I. S. Rounds, MD
Gerard M. Turino, MD
Jo Rae Wright, PhD†
INDIVIDUAL GIFTS
VISIONARIES: $10,000 OR MORE
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David W. Cugell, MD
James F. Donohue, MD
Francis Family Foundation
Freeman Decorating Services, Inc.
Susan Nestor
University of Alabama at Birmingham, Division
of Pulmonary, Allergy, and Critical Care
Medicine—Victor J. Thannickal, MD, and
William C. Bailey, MD
INNOVATORS: $5,000–$9,999
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Rebecca Bascom, MD, MPH
Brigham and Women’s Hospital
Sonia Buist, MD
Peter Finn
Philip C. Hopewell, MD
Ohio State University Medical Center
Dean E. Schraufnagel, MD
Marvin I. Schwarz, MD
Gerard M. Turino, MD
University of California-San Diego, Division
of Pulmonary, Critical Care, and Sleep
Medicine—Atul Malhotra, MD
• University of Chicago, Division of Pulmonary
and Critical Care Medicine—Jesse B. Hall,
MD
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Pulmonary, Allergy, and Critical Care
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of Allergy, Pulmonary, and Critical Care
Medicine—Nizar N. Jarjour, MD
FOUNDERS: $2,500–$4,999
• Boston University School of Medicine—David
Center, MD
• William W. Busse, MD
• Cedars-Sinai Medical Center
• Cleveland Clinic Respiratory Institute—Serpil
C. Erzurum, MD, and Herbert P. Wiedemann,
MD
• Michelle M. Cloutier, MD
• Stephen C. Crane, PhD, MPH
• Division of Pulmonary and Critical Care
Medicine, Washington University School of
Medicine—Michael J. Holtzman, MD
• Jeffrey L. Glassroth, MD
• Alan H. Jobe, MD, PhD
• Talmadge E. King Jr., MD
• Jerry A. Krishnan, MD, PhD
• William E. Lawson, MD and Laura L. Lawson,
MD
• Loma Linda University—Takkin Lo, MD
• Massachusetts General Hospital—Benjamin
Medoff, MD, and Andrew W. Tager, MD
• Richard A. Matthay, MD
• Susanna A. McColley, MD
• Perry G. Nystrom, MD
• Y. S. Prakash, MD, PhD
• Sharon I. S. Rounds, MD
• Sheldon L. Spector, MD
• Temple Lung Center/Temple Health—Gerard
J. Criner, MD
• University of California Los Angeles, Division
of Pulmonary and Critical Care Medicine—
Steven Dubinett, MD
• University of California San Diego, Rady
Children’s Hospital of San Diego, Division
of Pediatric Respiratory Medicine—James
Hagood, MD
• University of Colorado Denver—Mark W.
Geraci, MD
• University of Illinois at Chicago—Patricia W.
Finn, MD
• University of Southern California—Zea Borok,
MD, and Edward Crandall, MD
• Washington University in St. Louis, School
of Medicine, Departments of Pediatrics and
Medicine—Thomas W. Ferkol, MD
• Carolyn H. Welsh, MD
• Yale University—Naftali Kaminski, MD
DISCOVERERS: $1,000–$2,499
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Micheala Aldred, PhD
Donna J. Appell, RN
J. Steven Arnold, MD
David H. Au, MD, MS
Teresa Richardson Barnes
Thomas P. Bleck, MD
Mark L. Brantly, MD
Shannon S. Carson, MD
George H. Caughey, MD
Children’s Hospital of Philadelphia—Howard
B. Panitch, MD, and Julian Allen, MD
John W. Christman, MD
Vanessa J. Craig, MD
Myrna Crain
James D. Crapo, MD
J. Randall Curtis, MD, MPH
Jeffrey L. Curtis, MD
Robert DeMarco, MD
Loren C. Denlinger, MD, PhD
Robin R. Deterding, MD
Gregory B. Diette, MD
Michael P. Donahoe, MD
Jeffrey M. Drazen, MD
Jack A. Elias, MD
Leonardo M. Fabbri, MD
Arthur F. Gelb, MD
Lynn B. Gerald, PhD, MSPH
Roger S. Goldstein, MD
LeRoy Graham Jr., MD
Robin L. Gross, MD
Rebecca S. Gruchalla, MD, PhD
Nicola A. Hanania, MD, MS
C. Michael Hart, MD
Paul M. Hassoun, MD
Nicholas S. Hill, MD
Howard J. Huang, MD
Dana G. Kissner, MD
James R. Klinger, MD
Monica Kraft, MD
Janet Lee, MD
Kenneth V. Leeper, MD
David M. Lewinsohn, MD, PhD
Louis S. Libby, MD
Craig M. Lilly, MD
Gerald M. Loughlin, MD
Richard J. Martin, MD
Thomas R. Martin, MD
Robert J. Mason, MD
Bethany B. Moore, PhD
Alan H. Morris, MD
Marc Moss, MD
Alfred Munzer, MD
Richard K. Murray, MD
Jay A. Nadel, MD
Samya Z. Nasr, MD
National Board for Respiratory Care
Lydia Neumann
Mary A. Nevin, MD
Linda Nici, MD
Heber C. Nielsen, MD
Mitchell A. Olman, MA, MD
Amit D. Parulekar, MD
Susheel P. Patil, MD, PhD
Penn Respiration Group—John H. HansenFlaschen, MD
Marc Peters-Golden, MD
Charles A. Powell, MD
J. Usha Raj, MD
David M. Rapoport, MD
Lee B. Reichman, MD, MPH
Theodore F. Reiss, MD, MBE
Stephen I. Rennard, MD
David Riccio
Karen M. Ridge, PhD
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William N. Rom, MD, MPH
Bernard J. Roth, MD
Jonathan M. Samet, MD
David A. Schwartz, MD
Steven Shak, MD
John W. Shigeoka, MD
Ryan Snyder
Brian Derris Southern, MD
Roger G. Spragg, MD
Kent Steele
Charlie B. Strange III, MD
Robert M. Strieter, MD
Kingman P. Strohl, MD
Albert S. Sun, MD
Elizabeth K. Tam, MD
Gregory N. Thompson, MD
Bruce C. Trapnell, MD
Michelle Turenne
Vanderbilt University, Division of Allergy,
Pulmonary, and Critical Care Medicine
Shekhar T. Venkataraman, MD
William M. Vollmer, PhD
Jeffrey S. Wagener, MD
David Warburton, MD
Lorraine B. Ware, MD
Debra E. Weese-Mayer, MD
Gail G. Weinmann, MD
Sally E. Wenzel-Morganroth, MD
Mark D. Wewers, MD
Mary Ellen Wewers, PhD
Eric S. White, MD
Ok Hi Yoo, MD
PIONEERS: $500–$999
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Jerrold L. Abraham, MD
Andrea J. Apter, MA, MD, MSc
Charles W. Atwood Jr., MD
M. Safwan Badr, MD
Raquel R. Bartz, MD, MMCi
James M. Beck, MD
Timothy D. Bigby, MD
Peter B. Bitterman, MD
Zea Borok, MD
Jane Elizabeth Bourke, BS(Hons), PhD
V. Courtney Broaddus, MD
Steven L. Brody, MD
Derek E. Byers, MD, PhD
Christy Cappelletti, BPharm, PharmD
Brent Carter, MD
Antonino Catanzaro, MD
Brian W. Christman, MD
Convention Data Services
Ernest K. Cotton, MD
Courtney Crim Sr., MD
David E. Dines, MD
Anne E. Dixon, MD
Gregory P. Downey, MD
Drexel Medicine—Edward S. Schulman, MD
Anthony D. D’Urzo, MD
Element Designs
David J. Erle, MD
Karen A. Fagan, MD
Daniel C. Files, MD
Christine S. Fukui, MD
Michelle A. Gill
David Gozal, MD
Michael B. Green, MBA, MD
John E. Heffner, MD
Mary Elizabeth C. Hernandez, MD
Leslie A. Hoffman, PhD
Fernando Holguin, MD, MPH
Douglas B. Hornick, MD
David L. Hotchkin, MSc, MD
Terri Lee Hough, MD, MSc
see DONORS page 14
14
DONORS
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Rolf D. Hubmayr, MD
Omar Hussain, DO
Robert E. Hyatt, MD
David H. Ingbar, MD
Kazuo Isono, MD
Shannon Jamieson
Seong-Joo Jeong, MD
Naftali Kaminski, MD
David W. Kamp, MD
Gwendolyn Kerby, MD
Gurjit Khurana Hershey, MD, PhD
Dong Soon Kim, MD, PhD
John Kimball
Robert A. Klocke, MD
Jane Q. Koenig, PhD
Geoffrey Kurland, MD
Janet L. Larson, PhD, RN
Robert F. Lemanske Jr., MD
Shu S. Lin, MD, PhD
James E. Loyd, MD
David M. Mannino III, MD
Clay B. Marsh, MD
Andrew A. Martin, MD
William J. Martin II, MD
Gustavo Matute-Bello, MD
Janet R. Maurer, MD
Frank J. Mayo, MD
Stephen A. McCurdy, MD, MPH
Tom McKarns
Atul C. Mehta, MBBS
Peter E. Morris, MD
Andrew M. Namen, MD
Edward T. Naureckas, MD
Harold S. Nelson, MD
Lawrence M. Nogee, MD
Angela Panoskaltsis-Mortari, PhD
Ohio State University College of Nursing
Sam B. Patel, RPh, MBA
James R. Patterson, MD
Alan L. Plummer, MD
Vsevolod Y. Polotsky, MD, PhD
Mark A. Powers, MD
Ravindra C. Rajmane, MD
S. Bhimsen S. Rao, MD
Carrie A. Redlich, MD, MPH
Susan S. Redline, MD
Jeremy B. Richards, MD, MA
Andrew L. Ries, MD, MPH
Richard A. Robbins, MD
John D. Roehrs, MD
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Cecile S. Rose, MD, MPH
Margaret Rosenfeld, MD
David P.L. Sachs, MD
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Sanjay Sethi, MD
Alessandro Sette
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Chang S. Shim, MD
Thomas M. Siler, MD
Lewis J. Smith, MD
Howard Sohn
Christine A. Sorkness, PharmD
Ronald L. Sorkness, PhD
Peter H. S. Sporn, MD
Michael L. Stanchina, MD
John E. Stevenson, MD
Thomas B. Stibolt Jr., MD
Paul C. Stillwell, MD
Stuart W. Stoloff, MD
Taylor Thompson, MD
J. Daryl Thornton, MD, MPH
Louis P. Voigt, MD
Judith A. Voynow, MD
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Jeanne M. Wallace, MD
Angela C. Wang, MD
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Lisa R. Young, MD
Pamela L. Zeitlin, MD, PhD
Richard L. Zuwallack, MD
INVESTIGATORS: $250–$499
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Yossef Aelony, MD
Mohinder P. Ahluwalia, MD
Reshma Amin, MD
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Kewal Asosingh, PhD
Kamran Atabai, MD
Patrice T. Attal, MD
Christine Marie Aubry, MD
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John Bernardo, MD
Jonathan A. Bernstein, MD
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Gordon R. Bloomberg, MD
Jeffrey B. Bloomer, MD
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Eoin Brodie
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Alexander G. Duarte, MD
Edward Eden, MD
Marie E. Egan, MD
Alison C. P. Elder, PhD
Marlowe W. Eldridge, MD
Darlene J. Elias, MD
Charles W. Emala Sr., MD
Joshua Englert
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Humam Farah, MD, and The Farah Family
Trust
Joshua Patrick Fessel, MD, PhD
Henry E. Fessler, MD
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Janet Fox, MD
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Etsuo Fujita, MD
Peter Gehr, PhD
James E. Gern, MD
Ronaldo C. Go, MD
John J. Godleski, MD
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John I. Gotchall, MD
Michael K. Gould, MD, MS
Yvette M. Gozzo, MD
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David M. Guidot, MD
Susan H. Guttentag, MD
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Teal S. Hallstrand, MD, MPH
Jack R. Harkema, DVM, PhD
Michelle S. Harkins, MD
Tina V. Hartert, MD, MPH
Paul K. Henneberger, ScD
Robert Duncan Hite, MD
Joseph H. Hoffman, MD
Anne E. Holland, PhD
Laurence Huang, MD
Yuh-Chin T. Huang, MHS, MD
Robert C. Hyzy, MD
Jonathan S. Ilowite, MD
Yoshikazu Inoue
Elliot Israel, MD
Myron H. Jacobs, MD
Jeffrey R. Jacobson, MD
Christine R. Jenkins, MD, MBBS
Martin F. Joyce-Brady, MD
Robert J. Kaner, MD
John Karafilidis
Joel D. Kaufman, MD, MPH
Steven M. Kawut, MD, MS
Raouf A. Kayaleh, MD
Homayoun Kazemi, MD
H. William Kelly, PharmD
Jack Kelly, Lymphangiomatosis and
Gorham’s Disease Alliance
Anthony P. Khalifah, MD
Leila Kheirandish-Gozal, MSc, MD
R. John Kimoff, MD
Howard M. Kipen, MD, MPH
Steven Howard Kirtland, MD
Lawrence E. Kline, DO
Kirsten Marie Kloepfer, MD
Lester Kobzik, MD
Phillip E. Korenblat, MD
Stella Kourembanas, MD
Melissa Ann Kovach, MD
Anna Lam, MD
Lourdes R. Laraya-Cuasay, MD
Angeline A. Lazarus, MD
Stephen C. Lazarus, MD
Albin B. Leong, MD
Andrew H. Liu, MD
Neil R. MacIntyre, MD
Yolanda N. Mageto, MD, MPH
Jess Mandel, MD
Anthony M. Marinelli, MD
Guy B. Marks, MBBS, PhD
John G. Mastronarde, MD
Sadis Matalon, PhD
Praveen N. Mathur, MBBS
Francis X. McCormack, Jr., MD
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Don L. McNeil, MD
Michelle Deanna Miller, MD
Evelyn Montalvo Stanton, MD
Luis M. Moreta-Sainz, MD
Wayne J. Morgan, MD
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Leonard C. Moses, MD
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Genevieve Mylott
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Michael S. Niederman, MD
Theodore Oslick, MD
Robert Paine III, MD
Ulo Palm, MD
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David R. Park, MD
Gibbe H. Parsons, MD
Sanjay R. Patel, MD
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William Peppo, DO
Stephen P. Peters, MD, PhD
Irina Petrache, MD
Barbara A. Phillips, MD, MPH
Wanda Phipatanakul, MD
Kent E. Pinkerton, PhD
Michael I. Plotnick, MD
David J. Prezant, MD
Paul M. Quinton, PhD
Jonathan M. Raskin, MD
Lynn F. Reinke, PhD, APRN, BC
Clement L. Ren, MD
Herbert Y. Reynolds, MD
Linda Rogers, MD
James A. Rowley, MD
David Bernard Rubin, MD
Abdulghani Sankari, PhD, MD
Catherine S. Sassoon, MD
Edwin N. Schachter, MD
Michael Schatz, MD
Neil W. Schluger, MD
Scott A. Schroeder, MD
Paul T. Schumacker, PhD
Richard J. Schwab, MD
Jay Schwartz, MBA, RPh
Anthony S. Shen, MD
Rebecca A. Shilling, MD
Deborah Shure, MD
Jonathan M. Siner, MD
Benjamin David Singer, MD
Jonathan P. Singer, MS, MD
Cecilia M. Smith, DO
Angela R. Snydsman
Guy W. Soo Hoo, MD, MPH
Katharine Squires
Theodore J. Standiford, MD
Renee D. Stapleton, PhD, MD
Jeffrey R. Starke, MD
John L. Stauffer, MD
David A. Stempel, MD
Arvey M. Stone, MD
Eileen Storey, MD, MPH
Eugene J. Sullivan, MD
Stanley J. Szefler, MD
Donald P. Tashkin, MD
Markus K. Tauscher, MD
Peter B. Terry, MD
Krishna Thavarajah, MD
Alvin V. Thomas Jr., MD
Carey C. Thomson, MPH, MD
Jonathon D. Truwit, MBA, MD
Homer L. Twigg III, MD
Dona J. Upson, MA, MD
Steve Varon, MD
Diana E. Weaver, MD
Jadwiga A. Wedzicha, MD, PhD
Paul B. Weinberg, MD
Christine H. Wendt, MD
Sandra R. Wilson, PhD
Richard G. Wunderink, MD
Syed A. Zaidi, MD
Edward M. Zoratti, MD
STAFF CAMPAIGN
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Julia Acevedo
Meleta Adams
Muricia N. Alexander
Stephen Altobelli
Nicole Anthony
Marc Bendian
Nicola Black
May Ling Brantman
D’Ann Brown
Emily Catanzaro, CMP
Alyssa Z. Chase, MPH
Soledad Chauca
Kevin Chiu
Aashna Choudhary, PHR
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Eric Chu
Michael Clayton
Francine Comi
Judy Corn
Stephen C. Crane, PhD, MPH
Fran Du Melle
Nathaniel Dunford
Lara Endreszl
Gary Ewart
Daniel J. Fallon
Stephanie Fulgione
Dorcas Gelabert
Diane Gern
Nancy Guerrero
Eric Gumpert
Elizabeth Kay Guzman
Rhina Guzman, PHR
John Harmon
Syed O. Hassan
Barbara Horner
Laura Houston
Christopher L. Hughes
Jennifer A. Ian MBA, CAE
Vlada Kaganovskaya
Brian Kell
Neil Kerley
Duncan Krassikoff
Eileen Larsson
Kimberly Lawrence
Maribel Lim
Andre Lindsay
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Mary Mobley
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Katharine T. Moore
Nuala Moore
Erin Marie Nebel, MA
Lydia Neumann
Kyle O’Donnell
Catherine O’Hare
Shannon L. Payne
Dioliver Perez
Matthew Reid
Jessica Lynn Rivera, MBA
Miriam Rodriguez
Liliana Rozon
Aprille Russell
Jennifer Siegel-Gasiewski
Sean Slifer
Michelle Turenne
Sherryl-Anne F. Vega
Courtney White
Rory Williams
Kevin C. Wilson, MD
IN MEMORY OF
• In Memory of Juan Acevedo
Julia Acevedo
• In Memory of Sanford Adler
Robert H. Brown, MD
• In Memory of Diane Argiros
Christopher L. Hughes
• In Memory of Mary Lynn Badr
M. Safwan Badr, MD
• In Memory of David V. Bates, MD
George D. Thurston, DSc
• In Memory of Betty June Behney
Alice M. Boylan, MD
• In Memory of Therese Blackshaw
Stacy McManus, CEM
• In Memory of Jeannie Carlson
Vince McGee
Rose Marie McSwiggin
• In Memory of Dwayne Chapman
Elizabeth Kay Guzman
• In Memory of Young Soo Choi, MD
Joshua Englert
• In Memory of Willa Mae Clark
Mary Mobley
• In Memory of Rose Comi
Francine Comi
• In Memory of Leo Cosgrove
Gregory P. Cosgrove, MD
• In Memory of Marjo Dorine Crain
Myrna Crain
• In Memory of Benjamin Boyce Davis, PhD,
MS
George Cardinet Anna Karnopp
• In Memory of Gabriel Elias, MD
Erica Herzog, MD, PhD
• In Memory of Carl Fifield
David W. Kamp, MD
• In Memory of Julian Guidot, MD
David M. Guidot, MD
• In Memory of Burt Gusky
Jeffrey A. Gold, MD
• In Memory of Fatima Tammy Hernandez
Mary Elizabeth C. Hernandez, MD
• In Memory of Stuart J. Hirst, PhD
Jane Elizabeth Bourke, BS(Hons), PhD
• In Memory of Roland H. Ingram, MD
Stephen H. Loring, MD
• In Memory of Joe Kirby
Gary Ewart
• In Memory of Mary Lou Leeds
C. Sheri and Ken Leeds Sr.
15
• In Memory of Averill Liebow, MD
• In Memory of Barbara and Patrick McDermott
Shane McDermott
• In Memory of Robert Mellins, MD
Beverley J. Sheares, MD, MS
Jeffrey S. Wagener, MD
• In Memory of Pauline Mendelowitz
Carrie and Carl Helmsmeier
• In Memory of Frances Mularski
Richard A. Mularski, MD
• In Memory of Raymond C. Myers
United States Bankruptcy Court—
Northern District of Ohio
• In Memory of Julio Naranjo
Nancy Guerrero
• In Memory of Frederick Owen
Caroline A. Owen, MD, PhD
• In Memory of Glenn Eugene Parris
Michelle and Lars Bader
Kevin Creedon
Bob Dwyer
Patti Gowan
Beata Klecha
Ashlyn Kress
Kamal Maragh
Scott Mitchell
David Musselman
Mike Pierce
Matthew Price
Sarah Stevens
Rick Van Vleet
• In Memory of Dulce Perez
Dioliver Perez
see DONORS page 18
T:21
Find out
more
About
oFev At
BOOTH #301
Copyright ©2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (03/15) PC-OF-0112-PROF
1.5”
18
DONORS
• In Memory of Rosa M. Reed
Jessica Lynn Rivera, MBA
• In Memory of Wayne Reilly
Robert H. Brown, MD
• In Memory of Cecilia Rodriguez
• In Memory of Bill Wells
James C. Lavelle IV, MD
• In Memory of Mary Ellen and Martin Wohl
Dennis C. Stokes, MD, MPH
• In Memory of Jo Rae Wright, PhD
Eileen Larsson
Brian Kell
• In Honor of Reuben M. Cherniack, MD
Songul Buyukkale, MD
Alfred Munzer, MD
• In Honor of William W. Busse, MD
Rebecca S. Gruchalla, MD, PhD
Cecile S. Rose, MD, MPH
• In Honor of Dr. Margot Becklake as a pioneer
Gurjit Khurana Hershey, MD, PhD
• In Memory of Bill Simonds
in capacity building for pulmonary research in
Nizar N. Jarjour, MD
Africa
David M. Lang, MD
Rebecca Bascom, MD, MPH
Marc Rothenberg, MD
Katharine Squires
Mark L. Brantly, MD
M. Patricia Rivera, MD
• In Honor of Patricia Finn, MD
Peter Finn
• In Honor of Richard Hyde, MD
Gordon R. Bloomberg, MD
IN HONOR OF
• In Memory of Gordon Snider, MD
• In Honor of James F. Donohue, MD
Yelda Varol, MD
Susanna A. McColley, MD
Kristen Pomponio
• In Memory of Earl Rose, MD
Talmadge E. King Jr., MD
• In Honor of A. Sonia Buist, MD
• In Honor of Carl Booberg
John W. Shigeoka, MD
• In Honor of Monica Kraft, MD
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Thomas Newman
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Lawrence Schwartz, MD
Alan H. Morris, MD
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Product Services and Showcase
Anne I. Sperling, PhD
• In Honor of Lynn F. Reinke, PhD, APRN, BC
DorAnne M. Donesky, PhD, ANP-BC
• In Honor of Marvin I. Schwarz, MD
David A. Schwartz, MD
Dear Clot,
• In Honor of Clare Sime
It’s time to dissolve
this relationship.
Patricia J. Sime, MD
• In Honor of B.K. Singaraju, MD
Raj Singaraju
• In Honor of Pamela Chauca and Jonathan
Marin
Soledad Chauca
How Do You Treat PE?
See us at Booth #321
IN HONOR OF MY MENTOR
• In Honor of My Mentor Edward Block, MD
Introducing the only endovascular
device cleared by the FDA for the
treatment of pulmonary embolism.
C. Michael Hart, MD
• In Honor of My Mentor Homer Boushey, MD
FDA CLEARED INDICATIONS: The EkoSonic® Endovascular System is indicated for the ultrasound-facilitated,
controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature
for the treatment of pulmonary embolism; the controlled and selective infusion of physician-specified fluids,
including thrombolytics, into the peripheral vasculature; and the infusion of solutions into the pulmonary
arteries. Instructions for use, including warnings, precautions, potential complications, and contraindications
can be found at www.ekoscorp.com. Caution: Federal (USA) law restricts these devices to sale by or on
the order of a physician.
Steven Shak, MD
• In Honor of My Mentor John Butler, MD
EKOS CORPORATION | 11911 N. Creek Pkwy S. | Bothell, WA 98011 | 888.400.3567 | EKOSCORP.COM
EKOS and EkoSonic are registered trademarks of EKOS Corporation, a BTG International group company.
BTG and the BTG roundel logo are registered trademarks of BTG International Ltd in US, EU, and certain
other territories and trademarks of BTG International Ltd elsewhere.
Bruce H. Culver, MD
• In Honor of My Mentor Henry Chrystyn, MD
Wesam Ghazi Ammari, PhD
• In Honor of My Mentor W. Hal Cragun, MD
Bernard J. Roth, MD
• In Honor of My Mentor Nickolai Dulin, MD
Nathan K. Sandbo, MD
• In Honor of My Mentor Jack Elias, MD
Erica Herzog, MD, PhD
Switch to the Best….MIR Spirometry
Spirobank II Smart. The device is
supplied with an iOS based App for Real
Time Spirometry and Oximetry test on
your iPad/iPad Mini.
• In Honor of My Mentor James C. Hogg, MD
Claire M. Doerschuk, MD
• In Honor of My Mentor Steven Kawut, MD
Corey E. Ventetuolo, MD
• In Honor of My Mentor Richard A. Matthay, MD
Gulshan Sharma, MD, MPH
• In Honor of My Mentor Jay Nadel, MD
Arthur F. Gelb, MD
• In Honor of My Mentor David Orenstein, MD
Blakeslee E. Noyes, MD
• In Honor of My Mentor Polly Parsons, MD
Renee D. Stapleton, PhD, MD
• In Honor of My Mentor Thomas L. Petty, MD
Richard A. Matthay, MD
• In Honor of My Mentor Carrie Redlich, MD
The University of Nevada School of
Medicine Division of Pulmonary and Critical
Care Medicine in Las Vegas, Nevada is
seeking a Pulmonary and Critical Care
Physician. The successful candidate
will join a growing division that offers
a comprehensive mix of inpatient and
ambulatory teaching experiences for the
fellows, residents and medical students.
For more information, please contact
Dr. Hidenobu Shigemitsu at 702-671-2345
or [email protected].
AA/EOE Women and under-represented
groups are encouraged to apply. Positions
funded by Federal contracts may be subject to
the E-Verify process for employment eligibility
verification.
Mridu Gulati, MD
Booth #744
Disposable Masks
• In Honor of My Mentor Steven Sahn, MD
John E. Heffner, MD
• In Honor of My Mentor Henry Williams, MD
Ok Hi Yoo, MD
•
**These individuals have included the
ATS Foundation in their estate plans.
Lung Simulators
DLco Simulator & EasyLab QC Software
– check performance of Single-Breath
DLco Measurement equipment
Flow/Volume Simulator – generates ATS
& Custom Waveforms
Breathing Simulator – spontaneously
breathing lung model
†Deceased
S:10.25”
VISIT BOOTH 1157
TO YOUR PAH TREATMENT STRATEGY
LEARN ABOUT TYVASO, AN INHALED
PROSTACYCLIN, AT INDUSTRY THEATER #2
ON MONDAY, MAY 18 AT 11:45 am
An Industry Theater Presentation at the ATS 2015 International Conference. This presentation is sponsored by United Therapeutics. Due to regulatory restrictions,
this presentation is only available to attendees from the United States.
INDICATION
Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to
improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III
symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with
inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type
5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.
IMPORTANT SAFETY INFORMATION FOR TYVASO
• There are no adequate and well-controlled studies with Tyvaso
• Tyvaso is intended for oral inhalation only. Tyvaso is approved
in pregnant women. It is not known whether treprostinil is
for use only with the Tyvaso Inhalation System
excreted in human milk
• The safety and efficacy of Tyvaso have not been established
• The most common adverse events seen with Tyvaso in ≥4%
in patients with significant underlying lung disease (such as
of PAH patients and more than 3% greater than placebo in the
asthma or chronic obstructive pulmonary disease) and in
placebo-controlled clinical study were cough (54% vs 29%),
patients under 18 years of age. Patients with acute pulmonary
headache (41% vs 23%), throat irritation/pharyngolaryngeal
infections should be carefully monitored to detect any
pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%),
worsening of lung disease and loss of drug effect
and syncope (6% vs <1%)
• Tyvaso may increase the risk of bleeding, particularly in
patients receiving anticoagulants
Please see brief summary of Full Prescribing Information
• In patients with low systemic arterial pressure, Tyvaso may
on following page. For more information, please see Full
cause symptomatic hypotension. The concomitant use of
Prescribing Information, Patient Package Insert, and the
Tyvaso with diuretics, antihypertensives, or other vasodilators
Tyvaso Inhalation System Instructions for Use manual.
may increase the risk of symptomatic hypotension
These items are available at www.tyvaso.com.
• Hepatic or renal insufficiency may increase exposure to Tyvaso
and decrease tolerability. Tyvaso dosage adjustments may
For additional information about Tyvaso, visit www.tyvaso.com
be necessary if inhibitors of CYP2C8, such as gemfibrozil, or
or call 1-877-UNITHER (1-877-864-8437).
inducers of CYP2C8, such as rifampin, are added or withdrawn
Request a visit from a Tyvaso sales representative by
visiting www.tyvaso.com.
Tyvaso is a registered trademark of United Therapeutics Corporation.
© 2015 United Therapeutics Corporation. All rights reserved. US/TYV/FEB15/313(1)
S:10.25”
BRIEF SUMMARY
The following is a brief summary of the full prescribing information
for TYVASO® (treprostinil) Inhalation Solution. Please review the full
prescribing information prior to prescribing TYVASO.
INDICATIONS AND USAGE
TYVASO is a prostacyclin vasodilator indicated for the treatment of
pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise
ability. Studies establishing effectiveness included predominately patients
with NYHA Functional Class III symptoms and etiologies of idiopathic or
heritable PAH (56%) or PAH associated with connective tissue diseases
(33%). The effects diminish over the minimum recommended dosing
interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of
administration, nearly all controlled clinical experience with inhaled
treprostinil has been on a background of bosentan (an endothelin receptor
antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The
controlled clinical experience was limited to 12 weeks in duration.
CONTRAINDICATIONS
None.
Patients with Pulmonary Disease or Pulmonary Infections–The safety and
efficacy of TYVASO have not been established in patients with significant
underlying lung disease (e.g., asthma or chronic obstructive pulmonary
disease). Patients with acute pulmonary infections should be carefully
monitored to detect any worsening of lung disease and loss of drug effect.
Risk of Symptomatic Hypotension– Treprostinil is a pulmonary and systemic
vasodilator. In patients with low systemic arterial pressure, treatment with
TYVASO may produce symptomatic hypotension.
Patients with Hepatic or Renal Insufficiency–Titrate slowly in patients with
hepatic or renal insufficiency, because such patients will likely be exposed
to greater systemic concentrations relative to patients with normal hepatic
or renal function.
Risk of Bleeding–Since TYVASO inhibits platelet aggregation, there may
be an increased risk of bleeding, particularly among patients receiving
anticoagulant therapy.
Effect of Other Drugs on Treprostinil–Co-administration of a cytochrome
P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure
(both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme
inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased
exposure is likely to increase adverse events associated with treprostinil
administration, whereas decreased exposure is likely to reduce clinical
effectiveness.
ADVERSE REACTIONS
The following potential adverse reactions are described in Warnings and
Precautions:
• Decrease in systemic blood pressure • Bleeding
Adverse Reactions Identified in Clinical Trials–Because clinical trials
are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates
in the clinical trials of another drug and may not reflect the rates observed
in practice. In a 12-week placebo-controlled study (TRIUMPH I) of 235
patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III),
the most commonly reported adverse reactions to TYVASO included: cough
and throat irritation; headache, gastrointestinal effects, muscle, jaw or
bone pain, flushing and syncope. Table 1 lists the adverse reactions that
occurred at a rate of at least 4% and were more frequent in patients treated
with TYVASO than with placebo.
Tyvaso manufactured for: United Therapeutics Corporation
Research Triangle Park, NC 27709
Rx only February 2015
www.tyvaso.com
Table 1: Adverse Events in ≥4% of PAH Patients Receiving TYVASO and More Frequent* than Placebo
Adverse Event
Treatment n (%)
TYVASO
Placebo
n = 115
n = 120
Cough
62 (54)
35 (29)
Headache
Throat Irritation/
Pharyngolaryngeal Pain
Nausea
Flushing
Syncope
*More than 3% greater than placebo
47 (41)
27 (23)
29 (25)
17 (14)
22 (19)
13 (11)
17 (15)
7 (6)
1 (<1)
1 (<1)
The safety of TYVASO was also studied in a long-term, open-label extension
study in which 206 patients were dosed for a mean duration of 2.3 years
with a maximum exposure of 5.4 years. Eighty-nine (89%) percent of
patients achieved the target dose of nine breaths, four times daily. Fortytwo (42%) percent achieved a dose of 12 breaths four times daily. The
adverse events during this chronic dosing study were qualitatively similar
to those observed in the 12-week placebo controlled trial. Adverse Events
Associated with Route of Administration–Adverse events in the treated
group during the double-blind and open-label phase reflecting irritation
to the respiratory tract included: cough, throat irritation, pharyngeal pain,
epistaxis, hemoptysis and wheezing. Serious adverse events during the
open-label portion of the study included pneumonia in 15 subjects. There
were three serious episodes of hemoptysis (one fatal) noted during the
open-label experience. Adverse Reactions Identified in Post-Marketing
Experience–The following adverse reaction has been identified during the
postapproval use of Tyvaso. Because this reaction is reported voluntarily
from a population of uncertain size, it is not always possible to reliably
estimate the frequency or establish a causal relationship to drug exposure:
Angioedema
DRUG INTERACTIONS
Pharmacokinetic/pharmacodynamic interaction studies have not been
conducted with inhaled treprostinil (TYVASO); however, some of such
studies have been conducted with orally (treprostinil diolamine) and
subcutaneously administered treprostinil (Remodulin®).
Pharmacodynamics–Antihypertensive Agents or Other Vasodilators–
Concomitant administration of TYVASO with diuretics, antihypertensive
agents or other vasodilators may increase the risk of symptomatic
hypotension. Anticoagulants–Since treprostinil inhibits platelet
aggregation, there may be an increased risk of bleeding, particularly
among patients receiving anticoagulants.
Pharmacokinetics–Bosentan–In a human pharmacokinetic study
conducted with bosentan (250 mg/day) and an oral formulation of
treprostinil (treprostinil diolamine), no pharmacokinetic interactions
between treprostinil and bosentan were observed. Sildenafil–In a human
pharmacokinetic study conducted with sildenafil (60 mg/day) and an oral
formulation of treprostinil (treprostinil diolamine), no pharmacokinetic
interactions between treprostinil and sildenafil were observed. Effect of
Cytochrome P450 Inhibitors and Inducers–In vitro studies of human hepatic
microsomes showed that treprostinil does not inhibit cytochrome P450
(CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6,
CYP2E1 and CYP3A. Additionally, treprostinil does not induce cytochrome
P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A. Human
pharmacokinetic studies with an oral formulation of treprostinil (treprostinil
diolamine) indicated that co-administration of the cytochrome P450 (CYP)
2C8 enzyme inhibitor gemfibrozil increases exposure (both Cmax and AUC)
to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin
decreases exposure to treprostinil. It is unclear if the safety and efficacy of
treprostinil by the inhalation route are altered by inhibitors or inducers of
CYP2C8. Effect of Other Drugs on Treprostinil–Drug interaction studies have
been carried out with treprostinil (oral or subcutaneous) co-administered
with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole
(200 mg/day), respectively in healthy volunteers. These studies did not
show a clinically significant effect on the pharmacokinetics of treprostinil.
Treprostinil does not affect the pharmacokinetics or pharmacodynamics
of warfarin. The pharmacokinetics of R- and S-warfarin and the INR in
healthy subjects given a single 25 mg dose of warfarin were unaffected
by continuous subcutaneous infusion of treprostinil at an infusion rate of
10 ng/kg/min.
Pregnancy—Pregnancy Category B–There are no adequate and well
controlled studies with TYVASO in pregnant women. Animal reproduction
studies have not been conducted with treprostinil administered by the
inhalation route. However, studies in pregnant rabbits using continuous
subcutaneous (sc) infusions of treprostinil sodium at infusion rates higher
than the recommended human sc infusion rate resulted in an increased
incidence of fetal skeletal variations associated with maternal toxicity.
Animal reproduction studies are not always predictive of human response.
Labor and Delivery–No treprostinil treatment-related effects on labor and
delivery were seen in animal studies. The effect of treprostinil on labor and
delivery in humans is unknown.
Nursing Mothers–It is not known whether treprostinil is excreted in human
milk.
Pediatric Use–Safety and effectiveness in pediatric patients have not been
established. Clinical studies of TYVASO did not include patients younger
than 18 years to determine whether they respond differently from older
patients.
Geriatric Use–Clinical studies of TYVASO did not include sufficient numbers
of patients aged 65 years and over to determine whether they respond
differently from younger patients. In general, dose selection for an elderly
patient should be cautious, reflecting the greater frequency of hepatic,
renal, or cardiac dysfunction, and of concomitant diseases or other drug
therapy.
Patients with Hepatic Insufficiency–Plasma clearance of treprostinil,
delivered subcutaneously, was reduced up to 80% in subjects with mildto-moderate hepatic insufficiency. Uptitrate slowly when treating patients
with hepatic insufficiency because of the risk of an increase in systemic
exposure which may lead to an increase in dose-dependent adverse
effects. Treprostinil has not been studied in patients with severe hepatic
insufficiency.
Patients with Renal Insufficiency–No studies have been performed in
patients with renal insufficiency. Since treprostinil and its metabolites are
excreted mainly through the urinary route, patients with renal insufficiency
may have decreased clearance of the drug and its metabolites and
consequently, dose-related adverse outcomes may be more frequent.
OVERDOSAGE
In general, symptoms of overdose with TYVASO include flushing,
headache, hypotension, nausea, vomiting, and diarrhea. Provide
general supportive care until the symptoms of overdose have resolved.
Symposium
Examines Global
Threat of Air Pollution
A
ir pollution inflicts a huge burden of
illness—from respiratory problems
caused by asthma, COPD, and lung
cancer to non-respiratory issues brought on
by coronary artery disease, hypertension, and
cancer. Air pollution stunts lung growth and
increases susceptibility to respiratory infections in infants and children. Additionally,
it predisposes adults to respiratory diseases,
including asthma, bronchiolitis, COPD, and
lung cancer.
“Air Pollution: A Major Global Threat to
Lung Health” from 9:30 to 11:30 a.m. today
in Centennial Ballroom D (Third Floor) Hyatt
Regency Denver at the Colorado Convention Center, will bring together experts from
around the world to discuss the impact of
outdoor and indoor air pollution on lung
disease, consider ways of reducing the burden
of air pollution, and discuss
mechanisms of lung injury.
“Indoor air pollution
contributes to 75 percent
of COPD in developing
nations, affecting young
mothers and children who
are most heavily exposed
Gregory P. Downey
to smoke from fires and
cooking instruments indoors,” says Gregory
P. Downey, MD, executive vice president of
academic affairs at National Jewish Health
and professor of medicine at the University of
Colorado School of Medicine, Denver. “Understanding how air pollution contributes to lung
disease is critical in preventing and mitigating
the effects of air pollution.”
Dr. Downey is chair of the scientific symposium with three other experts: Peter J. Barnes,
DSc, MD, Margaret Turner-Warwick Chair
at the Imperial College of London; Sundeep
Salvi, MD, PhD, director of the Chest Research
Air Pollution: A Major Global Threat
to Lung Health
9:30 to 11:30 a.m. today
Centennial Ballroom D (Third Floor) Hyatt
Regency Denver at the Colorado Convention
Center
Foundation, Pune, India; and Ross Vlahos,
PhD, associate professor of clinical sciences at
the Royal Melbourne Institute of Technology.
Attendees will learn about the enormous
impact of air pollution on global lung health,
gain an understanding of the components of
indoor and outdoor air pollution that damage lung health, and learn about public health
measures needed to reduce air pollution and
lung disease.
Those interested in this session are also encouraged to attend “‘OMICS’ of Environmentally-Induced Lung Diseases” from 2:15 to
4:15 p.m. today. This mini symposium will be
held in the same location—Centennial Ballroom E (Third Floor) Hyatt Regency Denver
at the Colorado Convention Center.
21
Four to Receive Awards for Scientific Accomplishments
C
elebrate the achievements of four
expert researchers during the Recognition Awards for Scientific Accomplishments from 2:15 to 4:15 p.m. today
in Room 107/109/111/113 (Street Level) in
the Colorado Convention Center.
These awards are given to individuals for
outstanding scientific contributions in basic
or clinical research to the understanding,
prevention, and treatment of lung disease.
J.W. Christman, MD, Columbus, OH, and
P.W. Finn, MD, Chicago, IL, are chairs of
the session. Awardees will make 25-minute
presentations about their research.
• 2:15: Reynold A. Panettieri Jr., MD,
the University
of Pennsylvania,
Philadelphia,
presents “Airway
Smooth Muscle: A
Novel Therapeutic
Target in Severe
Reynold A.
Annie Pardo
Asthma.”
• 2:45: Annie Pardo, Panettieri Jr.
PhD, Universidad Nacional Autonoma
de Mexico, Mexico City, presents “Untan•
gling the Knot in IPF: Developing Irreversible Scars Despite Increased MMPs.”
• 3:15: William C. Parks, PhD, Cedars–
Sinai Medical Center, Los Angeles,
William C. Parks
Lorraine B. Ware
presents “MMPs in Lung Repair and
Fibrosis.”
3:45: Lorraine B. Ware, MD, Vanderbilt
University, Nashville, presents “Seeing
Red: Free Hemoglobin and the Pathogenesis of Sepsis and ARDS.”
B:21
T:
S:9.5”
The first and only once-daily ICS/LABA for the maintenance treatment of COPD
24
HOUR
Improves patients’ lung function for a full 24 hours with
one inhalation, once daily1*
Also approved to reduce COPD exacerbations in patients with a history of exacerbations
Indications
• BREO ELLIPTA is a combination inhaled corticosteroid/long-acting beta2 -adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance
treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
• BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
• BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Important Safety Information
WARNING: ASTHMA-RELATED DEATH
• Long-acting beta2 -adrenergic agonists (LABAs), such as
vilanterol, one of the active ingredients in BREO ELLIPTA,
increase the risk of asthma-related death. A placebo-controlled
trial with another LABA (salmeterol) showed an increase in
asthma-related deaths in subjects receiving salmeterol. This
finding with salmeterol is considered a class effect of all LABAs,
including vilanterol.
• The safety and efficacy of BREO ELLIPTA in patients with asthma
have not been established. BREO ELLIPTA is not indicated for
the treatment of asthma.
CONTRAINDICATIONS
• BREO ELLIPTA is contraindicated in patients with severe hypersensitivity
to milk proteins or who have demonstrated hypersensitivity to either
fluticasone furoate, vilanterol, or any of the excipients.
• BREO ELLIPTA should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD.
• BREO ELLIPTA should not be used for the relief of acute symptoms,
i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled,
short-acting beta2 -agonist.
• BREO ELLIPTA should not be used more often than recommended,
at higher doses than recommended, or in conjunction with other
medications containing LABAs, as an overdose may result. Clinically
significant cardiovascular effects and fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs. Patients
using BREO ELLIPTA should not use another medicine containing a LABA
(e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol)
for any reason.
• Oropharyngeal candidiasis has occurred in patients treated with
BREO ELLIPTA. Advise patients to rinse the mouth without swallowing
following inhalation to help reduce the risk of oropharyngeal candidiasis.
• An increase in the incidence of pneumonia has been observed in subjects
with COPD receiving BREO ELLIPTA. There was also an increased incidence
of pneumonias resulting in hospitalization. In some incidences these
pneumonia events were fatal.
— In replicate 12-month studies of 3255 subjects with COPD who
had experienced a COPD exacerbation in the previous year,
there was a higher incidence of pneumonia reported in subjects
receiving BREO ELLIPTA 100/25 mcg (6% [51 of 806 subjects]),
fluticasone furoate (FF)/vilanterol (VI) 50/25 mcg (6% [48 of
820 subjects]), and FF/VI 200/25 mcg (7% [55 of 811 subjects]) than in
subjects receiving VI 25 mcg (3% [27 of 818 subjects]). There was no
fatal pneumonia in subjects receiving VI or FF/VI 50/25 mcg. There was
fatal pneumonia in 1 subject receiving BREO ELLIPTA at the approved
strength (100/25 mcg) and in 7 subjects receiving FF/VI 200/25 mcg
(<1% for each treatment group).
• Physicians should remain vigilant for the possible development of
pneumonia in patients with COPD, as the clinical features of such
infections overlap with the symptoms of COPD exacerbations.
• Patients who use corticosteroids are at risk for potential worsening of
existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or
ocular herpes simplex. A more serious or even fatal course of chickenpox
or measles may occur in susceptible patients. Use caution in patients with
the above because of the potential for worsening of these infections.
• Particular care is needed for patients who have been transferred from
systemically active corticosteroids to inhaled corticosteroids because
deaths due to adrenal insufficiency have occurred in patients with asthma
during and after transfer from systemic corticosteroids to less systemically
available inhaled corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to BREO ELLIPTA.
• Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of inhaled corticosteroids in susceptible
individuals. If such changes occur, discontinue BREO ELLIPTA slowly.
• Caution should be exercised when considering the coadministration of
BREO ELLIPTA with long-term ketoconazole and other known strong
CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir,
itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin,
troleandomycin, voriconazole) because increased systemic corticosteroid
and cardiovascular adverse effects may occur.
• If paradoxical bronchospasm occurs, discontinue BREO ELLIPTA and
institute alternative therapy.
• Vilanterol can produce clinically significant cardiovascular effects in
some patients as measured by increases in pulse rate, systolic or diastolic
blood pressure, and also cardiac arrhythmias, such as supraventricular
tachycardia and extrasystoles. If such effects occur, BREO ELLIPTA may
need to be discontinued. BREO ELLIPTA should be used with caution in
patients with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension.
• Decreases in bone mineral density (BMD) have been observed with
long-term administration of products containing inhaled corticosteroids.
Patients with major risk factors for decreased bone mineral content,
such as prolonged immobilization, family history of osteoporosis,
postmenopausal status, tobacco use, advanced age, poor nutrition, or
chronic use of drugs that can reduce bone mass (e.g., anticonvulsants,
oral corticosteroids) should be monitored and treated with established
standards of care. Since patients with COPD often have multiple risk
factors for reduced BMD, assessment of BMD is recommended prior to
initiating BREO ELLIPTA and periodically thereafter.
1.25”
:21”
S:9.5”
Once-daily BREO ELLIPTA provided sustained improvement in lung function for a full 24 hours
PRIMARY ENDPOINT: BREO ELLIPTA provided a 220 mL improvement in weighted mean FEV1 (0-24 hours)
from period baseline compared with placebo (P<0.001) at end of the 28-day treatment period.1
Least squares (LS) mean change
from period baseline in FEV1 (mL)
SECONDARY ENDPOINT: SERIAL FEV1 (0-25 HOURS)1,2
Lung function assessed over 1 full day at Days 28 and 29
300
BREO (n=33)
Hour 25=166 mL
200
100
PLACEBO (n=51)
Hour 25=18 mL
0
–100
–200
0†
2
†
Zero=dose administration time
(between 6 AM and 10 AM).
4
6
8
12
16
HOURS POSTDOSE
20
22
24
*A multicenter, randomized,
double-blind, placebo-controlled,
crossover study evaluated the
effect of 28 days of treatment with
BREO ELLIPTA on lung function over
24 hours in 54 patients (mean age:
57.9 years) with COPD.‡ The primary
endpoint was weighted mean FEV1
(0-24 hours) at the end of the 28-day
treatment period (period Days 28 and
29). This was calculated from predose
FEV1 (mean of –30- and –5-minute
measurements) and postdose FEV1
after 5, 15, 30, and 60 minutes and
2, 4, 6, 8, 12, 16, 20, 22, 23, and
24 hours. The secondary endpoint
was serial FEV1 (0-25 hours) at
period Days 28 and 29.
At screening, patients had a mean postbronchodilator % predicted FEV1 of 49.8%, a mean postbronchodilator FEV1/FVC ratio of 52.9%, and a mean % reversibility of 8.8%.
FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity.
‡
In a separate 6-month lung-function study: a multicenter, randomized, double-blind, parallel-group study compared the effect of BREO vs
fluticasone furoate (FF) 100 mcg and vs placebo (each administered once daily by the ELLIPTA inhaler) on lung function in 1030 patients (mean
age: 62.7 years) with COPD.§ For the co-primary endpoints, BREO significantly improved weighted mean FEV1 (0-4 hours) postdose on Day 168
by 120 mL vs FFll and 173 mL vs placebo (P<0.001 for both); and BREO demonstrated a greater difference in LS mean change from baseline in
trough FEV1 at Day 169 of 115 mL vs placebo (95% CI: 60, 169; P<0.001); the 48 mL difference vs vilanterol 25 mcg¶ did not achieve statistical
significance (95% CI: –6, 102; P=0.082).2,3
At screening, patients had a mean postbronchodilator % predicted FEV1 of 48.3%, a mean postbronchodilator FEV1/FVC ratio of 47.6%, and a mean % reversibility of 15.9%.
The weighted mean comparison of BREO with FF, the ICS component, was assessed to evaluate the contribution of vilanterol to BREO. ICSs are not approved as monotherapy for COPD.
¶
The trough FEV1 comparison of BREO with vilanterol, the LABA component, was assessed to evaluate the contribution of FF to BREO. Vilanterol is not approved as monotherapy.
§
ll
Important Safety Information (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
• Glaucoma, increased intraocular pressure, and cataracts have been
reported in patients with COPD following the long-term administration
of inhaled corticosteroids. Therefore, close monitoring is warranted in
patients with a change in vision or with a history of increased intraocular
pressure, glaucoma, and/or cataracts.
• Use with caution in patients with convulsive disorders, thyrotoxicosis,
diabetes mellitus, ketoacidosis, and in patients who are unusually
responsive to sympathomimetic amines.
• Be alert to hypokalemia and hyperglycemia.
ADVERSE REACTIONS
• The most common adverse reactions (≥3% and more common than
placebo) reported in two 6-month clinical trials with BREO ELLIPTA (and
placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection,
7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%).
• In addition to the events reported in the 6-month studies, adverse
reactions occurring in ≥3% of the subjects treated with BREO ELLIPTA
in two 1-year studies included COPD, back pain, pneumonia, bronchitis,
sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza,
pharyngitis, diarrhea, peripheral edema, and pyrexia.
DRUG INTERACTIONS
• Caution should be exercised when considering the coadministration of
BREO ELLIPTA with long-term ketoconazole and other known strong
CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir,
itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin,
troleandomycin, voriconazole) because increased systemic corticosteroid
and cardiovascular adverse effects may occur.
• BREO ELLIPTA should be administered with extreme caution to
patients being treated with monoamine oxidase inhibitors, tricyclic
antidepressants, or drugs known to prolong the QTc interval, or within
2 weeks of discontinuation of such agents, because the effect of
adrenergic agonists, such as vilanterol, on the cardiovascular system may
be potentiated by these agents.
• Use beta-blockers with caution as they not only block the pulmonary
effect of beta-agonists, such as vilanterol, but may produce severe
bronchospasm in patients with reversible obstructive airways disease.
• Use with caution in patients taking non–potassium-sparing diuretics,
as electrocardiographic changes and/or hypokalemia associated with
non–potassium-sparing diuretics may worsen with concomitant
beta-agonists.
• Use BREO ELLIPTA with caution in patients with moderate or severe
hepatic impairment. Fluticasone furoate exposure may increase in these
patients. Monitor for systemic corticosteroid effects.
References: 1. Boscia JA, Pudi KK, Zvarich MT, Sanford L, Siederer SK, Crim C. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive
pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012;34(8):1655-1666. 2. Data on file, GSK. 3. Kerwin EM, Scott-Wilson C, Sanford L, et al. A randomised
trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. Respir Med. 2013;107(4):560-569.
Please see Brief Summary of Prescribing Information, including Boxed Warning, for BREO ELLIPTA on the following pages.
www.breoinfo.com
BREO ELLIPTA was developed in collaboration with
©2015 GSK group of companies.
All rights reserved. Printed in USA. 320114R0 March 2015
B:21.2
T:21
S:9.5”
BREO ELLIPTA
BRIEF SUMMARY
(fluticasone furoate and vilanterol inhalation powder)
FOR ORAL INHALATION USE
The following is a brief summary only; see full prescribing information for complete product information.
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from
a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo
added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving
salmeterol. This finding with salmeterol is considered a class effect of LABA, including vilanterol, an
active ingredient in BREO® ELLIPTA® [see Warnings and Precautions (5.1)].
The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established.
BREO ELLIPTA is not indicated for the treatment of asthma.
1 INDICATIONS AND USAGE
BREO ELLIPTA is a combination inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) indicated for
the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce
exacerbations of COPD in patients with a history of exacerbations.
Important Limitations of Use: BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the
treatment of asthma.
4 CONTRAINDICATIONS
The use of BREO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have
demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients [see Warnings and
Precautions (5.11), Description (11) of full prescribing information].
5 WARNINGS AND PRECAUTIONS
5.1 Asthma-Related Death Data from a large placebo-controlled trial in subjects with asthma showed that LABA
may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in
patients with COPD is increased by LABA. A 28-week, placebo-controlled, US trial comparing the safety of another
LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths
in subjects receiving salmeterol (13/13,176 in subjects treated with salmeterol vs 3/13,179 in subjects treated with
placebo; relative risk: 4.37 [95% CI: 1.25, 15.34]). The increased risk of asthma-related death is considered a class
effect of LABA, including vilanterol, one of the active ingredients in BREO ELLIPTA. No study adequate to determine
whether the rate of asthma-related death is increased in subjects treated with BREO ELLIPTA has been conducted.
The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established. BREO ELLIPTA is not
indicated for the treatment of asthma.
5.2 Deterioration of Disease and Acute Episodes BREO ELLIPTA should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD. BREO ELLIPTA has not been studied in patients
with acutely deteriorating COPD. The initiation of BREO ELLIPTA in this setting is not appropriate. BREO ELLIPTA
should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. BREO ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not
be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist. When
beginning treatment with BREO ELLIPTA, patients who have been taking oral or inhaled, short-acting beta2-agonists
on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and to use
them only for symptomatic relief of acute respiratory symptoms. When prescribing BREO ELLIPTA, the healthcare
provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on how it should
be used. Increasing inhaled, short-acting beta2-agonist use is a signal of deteriorating disease for which prompt
medical attention is indicated. COPD may deteriorate acutely over a period of hours or chronically over several days
or longer. If BREO ELLIPTA no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting,
beta2-agonist becomes less effective; or the patient needs more short-acting beta2-agonist than usual, these may
be markers of deterioration of disease. In this setting a re-evaluation of the patient and the COPD treatment regimen
should be undertaken at once. Increasing the daily dose of BREO ELLIPTA beyond the recommended dose is not
appropriate in this situation.
5.3 Excessive Use of BREO ELLIPTA and Use With Other Long-Acting Beta2-Agonists BREO ELLIPTA should
not be used more often than recommended, at higher doses than recommended, or in conjunction with other
medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have
been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BREO ELLIPTA
should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate,
indacaterol) for any reason.
5.4 Local Effects of Inhaled Corticosteroids In clinical trials, the development of localized infections of the mouth
and pharynx with Candida albicans has occurred in subjects treated with BREO ELLIPTA. When such an infection
develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with
BREO ELLIPTA continues, but at times therapy with BREO ELLIPTA may need to be interrupted. Advise the patient to
rinse his/her mouth without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.
5.5 Pneumonia An increase in the incidence of pneumonia has been observed in subjects with COPD receiving the
fluticasone furoate/vilanterol combination, including BREO ELLIPTA 100 mcg/25 mcg, in clinical trials. There was
also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events
were fatal. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as
the clinical features of such infections overlap with the symptoms of COPD exacerbations. In replicate 12-month
trials in 3,255 subjects with COPD who had experienced a COPD exacerbation in the previous year, there was a
higher incidence of pneumonia reported in subjects receiving the fluticasone furoate/vilanterol combination
(50 mcg/25 mcg: 6% [48 of 820 subjects]; 100 mcg/25 mcg: 6% [51 of 806 subjects]; or 200 mcg/25 mcg:
7% [55 of 811 subjects]) than in subjects receiving vilanterol 25 mcg (3% [27 of 818 subjects]). There was no fatal
pneumonia in subjects receiving vilanterol or fluticasone furoate/vilanterol 50 mcg/25 mcg. There was fatal
pneumonia in 1 subject receiving fluticasone furoate/vilanterol 100 mcg/25 mcg and in 7 subjects receiving
fluticasone furoate/vilanterol 200 mcg/25 mcg (less than 1% for each treatment group).
5.6 Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to
infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal
course in susceptible children or adults using corticosteroids. In such children or adults who have not had these
diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and
duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The
contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient
is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient
is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the
respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment
with antiviral agents may be considered. Inhaled corticosteroids should be used with caution, if at all, in patients
with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic
infections; or ocular herpes simplex.
5.7 Transferring Patients From Systemic Corticosteroid Therapy Particular care is needed for patients who have
been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal
insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less
systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months
are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously
maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their
systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients
may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly
gastroenteritis) or other conditions associated with severe electrolyte loss. Although BREO ELLIPTA may control
COPD symptoms during these episodes, in recommended doses it supplies less than normal physiological amount
of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with
these emergencies. During periods of stress or a severe COPD exacerbation, patients who have been withdrawn
from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and
to contact their physicians for further instruction. These patients should also be instructed to carry a warning card
indicating that they may need supplementary systemic corticosteroids during periods of stress or severe COPD
exacerbation. Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after
transferring to BREO ELLIPTA. Prednisone reduction can be accomplished by reducing the daily prednisone dose
by 2.5 mg on a weekly basis during therapy with BREO ELLIPTA. Lung function (mean forced expiratory volume in
1 second [FEV1]), beta-agonist use, and COPD symptoms should be carefully monitored during withdrawal of oral
corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as
fatigue, lassitude, weakness, nausea and vomiting, and hypotension. Transfer of patients from systemic corticosteroid
therapy to BREO ELLIPTA may unmask allergic conditions previously suppressed by the systemic corticosteroid
therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). During withdrawal from oral
corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint
and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function.
5.8 Hypercorticism and Adrenal Suppression Inhaled fluticasone furoate is absorbed into the circulation and can
be systemically active. Effects of fluticasone furoate on the HPA axis are not observed with the therapeutic dose
of BREO ELLIPTA. However, exceeding the recommended dosage or coadministration with a strong cytochrome
P450 3A4 (CYP3A4) inhibitor may result in HPA dysfunction [see Warnings and Precautions (5.9), Drug Interactions
(7.1)]. Because of the possibility of significant systemic absorption of inhaled corticosteroids in sensitive patients,
patients treated with BREO ELLIPTA should be observed carefully for any evidence of systemic corticosteroid effects.
Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of
inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal
suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects.
If such effects occur, BREO ELLIPTA should be reduced slowly, consistent with accepted procedures for reducing
systemic corticosteroids, and other treatments for management of COPD symptoms should be considered.
5.9 Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering
the coadministration of BREO ELLIPTA with long-term ketoconazole and other known strong CYP3A4 inhibitors
(e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir,
telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular
adverse effects may occur [see Drug Interactions (7.1), Clinical Pharmacology (12.3) of full prescribing information].
5.10 Paradoxical Bronchospasm As with other inhaled medicines, BREO ELLIPTA can produce paradoxical
bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with
BREO ELLIPTA, it should be treated immediately with an inhaled, short-acting bronchodilator; BREO ELLIPTA
should be discontinued immediately; and alternative therapy should be instituted.
5.11 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions such as anaphylaxis,
angioedema, rash, and urticaria may occur after administration of BREO ELLIPTA. Discontinue BREO ELLIPTA if such
reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after
inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should
not use BREO ELLIPTA [see Contraindications (4)].
5.12 Cardiovascular Effects Vilanterol, like other beta2-agonists, can produce a clinically significant cardiovascular
effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac
arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, BREO ELLIPTA may
need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiographic changes,
such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical
significance of these findings is unknown. In healthy subjects, large doses of inhaled fluticasone furoate/vilanterol
(4 times the recommended dose of vilanterol, representing a 12-fold higher systemic exposure than seen in patients
with COPD) have been associated with clinically significant prolongation of the QTc interval, which has the potential
for producing ventricular arrhythmias. Therefore, BREO ELLIPTA, like other sympathomimetic amines, should be
used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias,
and hypertension.
5.13 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with
long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes
in BMD with regard to long-term consequences such as fracture is unknown. Patients with major risk factors
for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis,
postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone
mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards
of care. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is
recommended prior to initiating BREO ELLIPTA and periodically thereafter. If significant reductions in BMD are seen
and BREO ELLIPTA is still considered medically important for that patient’s COPD therapy, use of medicine to treat or
prevent osteoporosis should be strongly considered. In replicate 12-month trials in 3,255 subjects with COPD, bone
fractures were reported by 2% of subjects receiving the fluticasone furoate/vilanterol combination (50 mcg/25 mcg:
2% [14 of 820 subjects]; 100 mcg/25 mcg: 2% [19 of 806 subjects]; or 200 mcg/25 mcg: 2% [14 of 811 subjects])
than in subjects receiving vilanterol 25 mcg alone (less than 1% [8 of 818 subjects]).
5.14 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients
with COPD following the long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted
in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. In
replicate 12-month trials in 3,255 subjects with COPD, similar incidences of ocular effects (including glaucoma and
cataracts) were reported in subjects receiving the fluticasone furoate/vilanterol combination (50 mcg/25 mcg: less than
1% [7 of 820 subjects]; 100 mcg/25 mcg: 1% [12 of 806 subjects]; 200 mcg/25 mcg: less than 1% [7 of 811 subjects])
as those receiving vilanterol 25 mcg alone (1% [9 of 818 subjects]).
5.15 Coexisting Conditions BREO ELLIPTA, like all medicines containing sympathomimetic amines, should be
used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive
to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered
intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
5.16 Hypokalemia and Hyperglycemia Beta-adrenergic agonist medicines may produce significant hypokalemia
in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular
effects. The decrease in serum potassium is usually transient, not requiring supplementation. Beta-agonist medications
may produce transient hyperglycemia in some patients. In 4 clinical trials of 6- and 12-month duration evaluating
BREO ELLIPTA in subjects with COPD, there was no evidence of a treatment effect on serum glucose or potassium.
6 ADVERSE REACTIONS
LABA, such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death.
BREO ELLIPTA is not indicated for the treatment of asthma. [See Boxed Warnings and Warnings and Precautions (5.1).]
Systemic and local corticosteroid use may result in the following: Increased risk of pneumonia in COPD [see Warnings
and Precautions (5.5)]; Increased risk for decrease in bone mineral density [see Warnings and Precautions (5.13)].
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of
another drug and may not reflect the rates observed in practice. The clinical program for BREO ELLIPTA included
7,700 subjects with COPD in two 6-month lung function trials, two 12-month exacerbation trials, and 6 other trials
of shorter duration. A total of 2,034 subjects have received at least 1 dose of BREO ELLIPTA 100 mcg/25 mcg, and
1,087 subjects have received higher doses of fluticasone furoate/vilanterol. The safety data described below are
based on the confirmatory 6-month and 12-month trials. Adverse reactions observed in the other trials were similar
to those observed in the confirmatory trials.
6-Month Trials: The incidence of adverse reactions associated with BREO ELLIPTA in Table 1 is based on 2 placebocontrolled, 6-month clinical trials (Trials 1 and 2; n = 1,224 and n = 1,030, respectively). Of the 2,254 subjects,
70% were male and 84% were Caucasian. They had a mean age of 62 years and an average smoking history of
44 pack years, with 54% identified as current smokers. At screening, the mean postbronchodilator percent
predicted FEV1 was 48% (range: 14% to 87%), the mean postbronchodilator FEV1/forced vital capacity (FVC) ratio
was 47% (range: 17% to 88%), and the mean percent reversibility was 14% (range: -41% to 152%). Subjects
received 1 inhalation once daily of the following: BREO ELLIPTA 100 mcg/25 mcg, fluticasone furoate/vilanterol
50 mcg/25 mcg, fluticasone furoate/vilanterol 200 mcg/25 mcg, fluticasone furoate 100 mcg, fluticasone furoate
200 mcg, vilanterol 25 mcg, or placebo.
25”
1”
S:9.5”
Table 1. Adverse Reactions With ≥3% Incidence and More Common Than Placebo With BREO ELLIPTA in Subjects
With Chronic Obstructive Pulmonary Disease
Adverse Event
Infections and infestations
Nasopharyngitis
Upper respiratory
tract infection
Oropharyngeal candidiasisa
Nervous system disorders
Headache
a
BREO ELLIPTA
100 mcg/25 mcg
(n = 410)
%
Vilanterol
25 mcg
(n = 408)
%
Fluticasone
Furoate
100 mcg
(n = 410)
%
Placebo
(n = 412)
%
9
10
8
8
7
5
4
3
5
2
3
2
7
9
7
5
Includes terms oral candidiasis, oropharyngeal candidiasis, candidiasis, and oropharyngitis fungal.
12-Month Trials: Long-term safety data is based on two 12-month trials (Trials 3 and 4; n = 1,633 and n = 1,622,
respectively). Trials 3 and 4 included 3,255 subjects, of which 57% were male and 85% were Caucasian. They had
a mean age of 64 years and an average smoking history of 46 pack years, with 44% identified as current smokers.
At screening, the mean postbronchodilator percent predicted FEV1 was 45% (range: 12% to 91%), and the mean
postbronchodilator FEV1/FVC ratio was 46% (range: 17% to 81%), indicating that the subject population had moderate
to very severely impaired airflow obstruction. Subjects received 1 inhalation once daily of the following: BREO ELLIPTA
100 mcg/25 mcg, fluticasone furoate/vilanterol 50 mcg/25 mcg, fluticasone furoate/vilanterol 200 mcg/25 mcg, or
vilanterol 25 mcg. In addition to the events shown in Table 1, adverse reactions occurring in greater than or equal to
3% of the subjects treated with BREO ELLIPTA (N = 806) for 12 months included COPD, back pain, pneumonia [see
Warnings and Precautions (5.5)], bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza,
pharyngitis, diarrhea, peripheral edema, and pyrexia.
6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse
reactions have been identified during postapproval use of BREO ELLIPTA. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency
of reporting, or causal connection to BREO ELLIPTA or a combination of these factors. Immune System Disorders:
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled trials with BREO ELLIPTA in
pregnant women. Corticosteroids and beta2-agonists have been shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. Because animal studies are not always predictive of human
response, BREO ELLIPTA should be used during pregnancy only if the potential benefit justifies the potential risk to
the fetus. Women should be advised to contact their physicians if they become pregnant while taking BREO ELLIPTA.
Fluticasone Furoate and Vilanterol: There was no evidence of teratogenic interactions between fluticasone furoate and
vilanterol in rats at approximately 9 and 40 times, respectively, the maximum recommended human daily inhalation
dose (MRHDID) in adults (on a mcg/m2 basis at maternal inhaled doses of fluticasone furoate and vilanterol, alone or in
combination, up to approximately 95 mcg/kg/day). Fluticasone Furoate: There were no teratogenic effects in rats and
rabbits at approximately 9 and 2 times, respectively, the MRHDID in adults (on a mcg/m2 basis at maternal inhaled doses
up to 91 and 8 mcg/kg/day in rats and rabbits, respectively). There were no effects on perinatal and postnatal development
in rats at approximately 3 times the MRHDID in adults (on a mcg/m2 basis at maternal doses up to 27 mcg/kg/day).
Vilanterol: There were no teratogenic effects in rats and rabbits at approximately 13,000 and 160 times, respectively, the
MRHDID in adults (on a mcg/m2 basis at maternal inhaled doses up to 33,700 mcg/kg/day in rats and on an AUC basis at
maternal inhaled doses up to 591 mcg/kg/day in rabbits). However, fetal skeletal variations were observed in rabbits at
approximately 1,000 times the MRHDID in adults (on an AUC basis at maternal inhaled or subcutaneous doses of
5,740 or 300 mcg/kg/day, respectively). The skeletal variations included decreased or absent ossification in cervical
vertebral centrum and metacarpals. There were no effects on perinatal and postnatal development in rats at approximately
3,900 times the MRHDID in adults (on a mcg/m2 basis at maternal oral doses up to 10,000 mcg/kg/day).
Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during
pregnancy. Such infants should be carefully monitored.
8.2 Labor and Delivery There are no adequate and well-controlled human trials that have investigated the effects
of BREO ELLIPTA during labor and delivery. Because beta-agonists may potentially interfere with uterine contractility,
BREO ELLIPTA should be used during labor only if the potential benefit justifies the potential risk.
8.3 Nursing Mothers It is not known whether fluticasone furoate or vilanterol are excreted in human breast milk.
However, other corticosteroids and beta2-agonists have been detected in human milk. Since there are no data
from controlled trials on the use of BREO ELLIPTA by nursing mothers, caution should be exercised when it is
administered to a nursing woman.
8.5 Geriatric Use Based on available data, no adjustment of the dosage of BREO ELLIPTA in geriatric patients is
necessary, but greater sensitivity in some older individuals cannot be ruled out. Clinical trials of BREO ELLIPTA for
COPD included 2,508 subjects aged 65 and older and 564 subjects aged 75 and older. No overall differences in safety
or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger subjects.
8.6 Hepatic Impairment Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic
impairment compared with healthy subjects. Hepatic impairment had no effect on vilanterol systemic exposure.
Use BREO ELLIPTA with caution in patients with moderate or severe hepatic impairment. Monitor patients for
corticosteroid-related side effects [see Clinical Pharmacology (12.3) of full prescribing information].
8.7 Renal Impairment There were no significant increases in either fluticasone furoate or vilanterol exposure in
subjects with severe renal impairment (CrCl<30 mL/min) compared with healthy subjects. No dosage adjustment
is required in patients with renal impairment [see Clinical Pharmacology (12.3) of full prescribing information].
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
BREO ELLIPTA: No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with BREO ELLIPTA;
however, studies are available for the individual components, fluticasone furoate and vilanterol, as described below.
Fluticasone Furoate: Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year
inhalation studies in rats and mice at inhaled doses up to 9 and 19 mcg/kg/day, respectively (approximately equal to
the MRHDID in adults on a mcg/m2 basis). Fluticasone furoate did not induce gene mutation in bacteria or chromosomal
damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of
genotoxicity in the in vivo micronucleus test in rats. No evidence of impairment of fertility was observed in male and
female rats at inhaled fluticasone furoate doses up to 29 and 91 mcg/kg/day, respectively (approximately 3 and 9 times,
respectively, the MRHDID in adults on a mcg/m2 basis).
Vilanterol: In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian
tubulostromal adenomas in females at an inhalation dose of 29,500 mcg/kg/day (approximately 8,750 times the
MRHDID in adults on an AUC basis). No increase in tumors was seen at an inhalation dose of 615 mcg/kg/day
(approximately 530 times the MRHDID in adults on an AUC basis). In a 2-year carcinogenicity study in rats, vilanterol
caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary
tumors at inhalation doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 45 times
the MRHDID in adults on an AUC basis). No tumors were seen at an inhalation dose of 10.5 mcg/kg/day (approximately
2 times the MRHDID in adults on an AUC basis). These tumor findings in rodents are similar to those reported previously
for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown. Vilanterol tested
negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in
vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested
equivocal in the in vitro mouse lymphoma assay. No evidence of impairment of fertility was observed in reproductive
studies conducted in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day,
respectively (approximately 12,000 and 14,000 times, respectively, the MRHDID in adults on a mcg/m2 basis).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
17.1 Asthma-Related Death Patients should be informed that LABA, such as vilanterol, one of the active ingredients in
BREO ELLIPTA, increase the risk of asthma-related death. BREO ELLIPTA is not indicated for the treatment of asthma.
17.2 Not for Acute Symptoms BREO ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses
should not be used for that purpose. Acute symptoms should be treated with a rescue inhaler such as albuterol.
The physician should provide the patient with such medicine and instruct the patient in how it should be used.
Patients should be instructed to notify their physicians immediately if they experience any of the following:
Symptoms get worse; Need for more inhalations than usual of their rescue inhaler; Significant decrease in lung
function as outlined by the physician. Patients should not stop therapy with BREO ELLIPTA without physician/
provider guidance since symptoms may recur after discontinuation.
17.3 Do Not Use Additional Long-Acting Beta2-Agonists When patients are prescribed BREO ELLIPTA, other
medicines containing a LABA should not be used.
17.4 Risks Associated With Corticosteroid Therapy
Local Effects: Patients should be advised that localized infections with Candida albicans occurred in the mouth
and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local
or systemic (i.e., oral) antifungal therapy while still continuing therapy with BREO ELLIPTA, but at times therapy with
BREO ELLIPTA may need to be temporarily interrupted under close medical supervision. Rinsing the mouth without
swallowing after inhalation is advised to help reduce the risk of thrush.
Pneumonia: Patients with COPD who have received BREO ELLIPTA have a higher risk of pneumonia and should be
instructed to contact their healthcare providers if they develop symptoms of pneumonia (e.g., fever, chills, change in
sputum color, increase in breathing problems).
Immunosuppression: Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid
exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Patients should be
informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular
herpes simplex.
Hypercorticism and Adrenal Suppression: Patients should be advised that BREO ELLIPTA may cause systemic corticosteroid
effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal
insufficiency have occurred during and after transfer from systemic corticosteroids.
Reduction in Bone Mineral Density: Patients who are at an increased risk for decreased BMD should be advised that the
use of corticosteroids may pose an additional risk.
Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or
glaucoma); regular eye examinations should be considered.
17.5 Risks Associated With Beta-Agonist Therapy Patients should be informed of adverse effects associated with
beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
17.6 Hypersensitivity Reactions, Including Anaphylaxis Advise patients that hypersensitivity reactions
(e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of BREO ELLIPTA. Instruct patients
to discontinue BREO ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients
with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients
with severe milk protein allergy should not use BREO ELLIPTA.
BREO and ELLIPTA are registered trademarks of the GSK group of companies.
BREO ELLIPTA was developed in collaboration with
.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2014, the GSK group of companies. All rights reserved.
Revised 09/2014
©2015 GSK group of companies.
All rights reserved. Printed in USA. 320114R0 March 2015
BRE:3BRS
S:12”
7 DRUG INTERACTIONS
7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate and vilanterol, the individual components of BREO ELLIPTA,
are both substrates of CYP3A4. Concomitant administration of the potent CYP3A4 inhibitor ketoconazole increases the
systemic exposure to fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration
of BREO ELLIPTA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin,
conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole)
[see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3) of full prescribing information].
7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Vilanterol, like other beta2-agonists, should
be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic
antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents,
because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
7.3 Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists,
such as vilanterol, a component of BREO ELLIPTA, but may produce severe bronchospasm in patients with reversible
obstructive airways disease. Therefore, patients with COPD should not normally be treated with beta-blockers. However,
under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for
these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
7.4 Non–Potassium-Sparing Diuretics The electrocardiographic changes and/or hypokalemia that may result from
the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened
by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical
significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–
potassium-sparing diuretics.
10 OVERDOSAGE
No human overdosage data has been reported for BREO ELLIPTA. BREO ELLIPTA contains both fluticasone furoate
and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply
to BREO ELLIPTA.
10.1 Fluticasone Furoate Because of low systemic bioavailability (15.2%) and an absence of acute drug-related
systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than
observation. If used at excessive doses for prolonged periods, systemic effects such as hypercorticism may occur
[see Warnings and Precautions (5.8)]. Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg
have been studied in human subjects. Decreases in mean serum cortisol were observed at dosages of 500 mcg or
higher given once daily for 14 days.
10.2 Vilanterol The expected signs and symptoms with overdosage of vilanterol are those of excessive beta-adrenergic
stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation
(e.g., angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness,
headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia,
hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and
even death may be associated with an overdose of vilanterol. Treatment of overdosage consists of discontinuation
of BREO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use
of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce
bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
26
OPENING CEREMONY
Calendar of Special Events
TODAY
6:45 to 7:45 a.m.
Pediatric Clinical Core Curriculum: “Radiology
for the Pediatric Pulmonologist”
Room 205/207 (Street Level)
6:45 to 8:15 a.m.
Critical Care Clinical Core Curriculum I
Bellco Theatre Section 1 (Street Level)
7 to 8 a.m.
Center for Career Development opens with
Meet and Greet with Fellows Track Symposium
Faculty and light complimentary breakfast
7 to 8 a.m.
“Lung Regeneration: An Achievable Mission”
Four Seasons Ballroom 1-2 (Lower Level)
9:30 to 11: 30 a.m.
1:15 to 2:15 p.m.
Unopposed Exhibit Hall Time
Halls D–F (Upper Level)
Basic Science Core: “How Pathogens Evade
Immune Defenses and How We Can Fight
Back”
Mile High Ballroom 2A/3A (Lower Level)
1:30 to 2:30 p.m.
9:30 to 11:30 a.m.
2:15 to 4:15 p.m.
Clinical Year in Review 2
10:30 a.m. to 5 p.m.
Exhibit Hall opens with complimentary coffee
Halls D–F (Upper Level)
Science and Innovation Center opens with light
complimentary breakfast
E Concourse (Street Level)
11 a.m. to 2:30 p.m.
7:30 to 8 a.m.
11:45 a.m. to 1:15 p.m.
Bistro ATS Opens in the Exhibit Hall
Hall F (Upper Level)
Clinicians Center opens with light complimentary breakfast
Women’s Forum: Judith Albino, PhD
Crystal Ballroom (3rd Floor)
Embassy Suites Hotel
8:30 to 9:15 a.m.
Center for Career Development: Early Career
Researchers Group with AJRCCM Editor Jadwiga Wedzicha, MD
ATS Discoveries Series:
“Two Billion and Counting: Reinvigorating the
Battle Against Our Old Foe, TB”
Noon to 1 p.m.
Science and Innovation Center: Scientific
Abstract Awards
Sleep Medicine Clinical Core Curriculum II
2:15 to 4: 15 p.m.
Basic Science Core: “Us Versus Them: Mucins
and Biofilms in the Battle for the Lungs”
Mile High Ballroom 2A/3A (Lower Level)
2:15 to 4:15 p.m.
Pediatric Year in Review
4 to 5 p.m.
Clinicians Center: Outstanding Clinician Award
Presentation
5 to 7 p.m.
Assembly Membership Meetings
For locations, visit conference.thoracic.
org/2015
journals, become principal investigators, and
mentored junior faculty,” Dr. Ferkol said.
On global health, Dr. Ferkol noted that the
ATS’s 15,000 members hail from 122 countries, and the Society maintains relationships
with sister societies around the world and is
a founding member of the Forum of International Respiratory Societies, a collaborative to
promote lung health. He also nodded to the
Methods in Epidemiologic, Clinical, and Operations Research (MECOR) program, which
strengthens capacity related to respiratory
conditions, critical care, and sleep medicine in
middle- and low-income countries. Afterward,
ATS President-Elect Atul Malhotra, MD,
was invited to describe the Global Scholars
Program, a new distance-learning initiative to
better improve medical education worldwide.
Lastly, Dr. Ferkol discussed the importance
of advocacy on legislative and regulatory issues
important to the organization, acknowledging
the staff in Washington, DC. He also noted
the importance of advocacy journalism, which
provided a segue to introducing Mr. Mandvi,
satirical humorist and senior correspondent on
Comedy Central’s The Daily Show.
He joked about interviews he has done for
the show and showed videos of several of his
favorite segments. When technical difficulties
stopped the first video, Mr. Mandvi drew loud
laughs by looking at the audio-visual crew and
saying, “People keep pointing at people … just
like doctors. ‘Hey, I’m just a pulmonary guy …
he’s the heart guy.’”
BECOME A CARE CENTER NETWORK SITE
PFF_ATS daily_1/2pg_F.indd 1
4/28/15 9:27 AM
DISCOVERIES
pluripotent cells can be created from cells
anywhere in a patient’s body, so they can
be gathered with minimal discomfort to
the patient. And, unlike ES cells, they are
genetically identical to the patient, minimizing the possibility of being rejected
when reintroduced into the body.
“Lung Regeneration: An Achievable Mission” is supported by an educational grant
from Lung Biotechnology.
TWO BILLION AND COUNTING:
REINVIGORATING THE BATTLE
AGAINST OUR OLD FOE, TB
Bellco Theatre Section 2 (Street Level),
Trevor Mundel, MD, PhD, president of
the global health program at the Bill and
Melinda Gates Foundation, will describe
the important progress the world has
made against tuberculosis over the past
20 years and the work that must continue.
TB remains a leading cause of death in
both developing and middle-income
countries. Current drugs, diagnostics,
vaccines, and delivery approaches are not
sufficient to sustain, let alone accelerate,
reductions in global incidence.
To bend the curve on tuberculosis prevention, diagnosis, and treatment, fundamental questions about the basic biology
of tuberculosis infection and disease must
be answered. For example, there is a need
to better understand TB transmission,
the different stages of the disease in the
human body, and its response or failure
to respond to treatment. There is also
need to develop and advance strategies
that accelerate access to existing and new
solutions.
The Bill and Melinda Gates Foundation is working with a wide range of
partners in the public and private sectors
to ensure the development and delivery
of better tools for TB control. It is also
seeking to create partnerships and expand existing collaborations to develop
improved host-directed therapies and
other transformational tools that can
shorten treatment and reduce the risk of
relapse and reinfection.
ATS Daily Bulletin
Rory Williams, Director
Lisa K. Brown, Manager
ATS Communications and Marketing
The ATS Daily Bulletin is published by
Ascend Integrated Media, LLC
for the ATS.
PAR Continued from page 8
The physicians also gained insights from
patients, including first-time presenter Rebecca
Keith, MD, assistant professor of medicine at
the University of Colorado School of Medicine,
Aurora.
“It’s exciting because it allows me as a
physician to understand what my patients are
learning and what they are interested in,” Dr.
Keith says. “I spent some time having lunch
with patients who have pulmonary fibrosis and
learning from them about what it’s like to deal
with this disease and how they get through
every day. How resilient they are and how they
manage to make the best out of each situation
and get involved in advocacy groups is really
impressive.”
Hands-on Skills in the Practical Workshops
P
articipate in 90 minutes of handson demonstrations and skillbuilding presentations with a
different exhibiting company each day in
the Practical Workshop located at the end
of the 100 aisle.
TODAY
12:30 to 2 p.m.
Bronchial Thermoplasty (BT):
Emerging Data and Real World
Experience
Bronchial Thermoplasty (BT), delivered
by the Alair™ System, is a safe and effective
outpatient procedure clinically proven
to last at least five years for adult patients
with severe asthma. Hear from physicians
about their real-world experience, patients
who can benefit from BT, emerging data,
and participate in a hands-on workshop. Includes boxed lunch.
Company: Boston Scientific Corporation
* Vermont law imposes additional restrictions when Vermont licensed HCPs are in
attendance. If you are licensed in Vermont,
please notify BSC immediately.
Jonathan Spahr, MD
Daniel Weiner, MD
Juan Celedón, MD, DrPH
Stephen Walczak, RRT
Challenging conventional treatments for
cystic fibrosis and asthma.
BEST
CHILDREN’S
HOSPITALS
HONOR ROLL
2014-15
27
At Children’s Hospital of Pittsburgh of UPMC, our research and clinical teams are investigating
every possibility to improve the quality of life for our patients with cystic fibrosis (CF) and
asthma. As a longstanding Therapeutics Development Network center, we are testing novel
drug therapies and other interventions to find better ways to treat CF. And our Pediatric Asthma
Center conducts NIH- and privately funded research on the role of genetics, epigenetics,
immunology, diet, obesity, and stress on childhood asthma, taking care to include underserved
minority children such as Puerto Ricans and African-Americans. To learn more about how we’re
helping children with cystic fibrosis and asthma, visit UPMCPhysicianResources.com/PedsPulm.
Photography by Steve Schneider and
R.C. Photographic Productions.
©2015 by the
American Thoracic Society
25 Broadway, 18th Floor
New York, New York 10004
(212) 315-8600
thoracic.org
Affiliated with the University of Pittsburgh School of Medicine and ranked among the nation’s best children’s hospitals by U.S. News & World Report.
28
Programs for Early Career Professionals Grow
During the ATS Resident Boot Camp, which attracted 140 residents, participants practice hands-on skills.
T
he ATS Fellows Track Symposium,
Resident Boot Camp, and Student
Scholars Program have become a huge
draw for early career professionals, with this
year’s attendance at 405, representing a 61
percent increase from last year.
So many residents applied for the 70 spots in
the Friday and Saturday Resident Boot Camp
that the program’s capacity was doubled to 140,
to satisfy the demand.
“The leadership felt it would not be appropriate to turn them down since one of our missions is to train the next generation of pulmonary care physicians. We doubled the program
and added a pediatric track,” says Resident Boot
Camp Course Chair and ATS Training Committee Vice Chair Laura Crotty Alexander, MD,
assistant clinical professor of medicine at the
University of California, San Diego.
Now in its second year, the Resident Boot
Camp prepares residents who are entering
pulmonary, critical care, and sleep fellowships
with small breakout sessions and skills-based
workshops with 85 faculty members.
“We know the best way to teach is in very
small groups with this generation of learners, so
we minimized the lectures to two hours a day
and the other six hours to small group sessions,”
Dr. Crotty Alexander says.
Planners set aside four hours each day to
show the groups how to perform bronchosocopy, intubation, heart and chest ultrasound,
spirometry, and mechanical ventilation.
“I think this is important for residents
because they will not have been exposed to a lot
of these things going into fellowship. Our hope
is that this will build their confidence for their
first day of fellowship,” says Brendan Clark,
MD, a member of the Resident Boot Camp
Planning Committee and an assistant professor of medicine at the University of Colorado
School of Medicine, Aurora.
The skills-based learning has been rewarding
for April McDonald, MD, a third-year resident
at the University of Tennessee, Knoxville.
“We’ve been doing ultrasound, bronchoscopy, and all kinds of things that will be pertinent
to when we begin [our fellowships]. It gives us a
leg up before we get started. It’s been a wonderful opportunity, and I’m thankful to be here,”
Dr. McDonald says.
This year, 200 fellows took part in the Fellows
Track Symposium. Faculty discussed clinical
issues related to the diagnosis and treatment of
a variety of pulmonary, critical care, and sleep
disorders, including sepsis, COPD, lung cancer,
asthma, and interventional pulmonology. It
also included four breakout sessions and an
ultrasonography dinner symposium.
“I’m going to take the pulmonary boards
this year, so I thought this was good fit,” says
Hrishikesh Kulkarni, MD, a second-year fellow
at Washington University, St. Louis. “There was
a wide spectrum of topics covered, and I think
the faculty did a great job covering them and
answering questions.”
Also this year, the Medical Student Scholar
Program was renamed the ATS Student Scholars Program to reflect the inclusion of attendees
from various professional backgrounds. That
program has grown from 31 to 65 attendees,
organizers note.
Sarah Haeger, an MD/PhD student studying acute lung injury for her thesis project at
the University of Colorado, is mindful of the
educational benefit, especially the opportunity
to talk with her fellow mentor.
“I’m excited to talk about how he got into
pulmonary and critical care medicine and the
path he has taken because I’m interested in
pulmonary critical care medicine,” Ms. Haeger
says.
The Resident Boot Camp is supported by an
educational grant from Olympus Corporation
of the Americas. In-kind support is provided
by Bryan Corporation; FUJIFILM SonoSite,
Inc.; Hamilton Medical, Inc.; Micro Direct, Inc.;
Olympus Corporation of the Americas; Richard
Wolf Medical Instruments Corp.; Smiths Medical; and Verathon.
The FTS is supported by educational grants
from Actelion Pharmaceuticals US, Inc.; AstraZeneca LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Genentech; and Sunovion Pharmaceuticals, Inc. In-kind support is provided
by FUJIFILM SonoSite, Inc.
Be Sure to Attend Industry Theaters and Mini Theaters
W
ith increasing popularity of Industry Theaters, ATS 2015 will deliver
more offerings than ever before.
Professionals will lead a total of 19 Industry
Theater and Mini Industry Theater discussions
in the Exhibit Hall. Have lunch while learning
about new product launches and treatment
options. Complimentary boxed lunch will be
provided by the ATS while supplies last.
TODAY
11:45 a.m. to 12:30 p.m.
Industry Theater 1
The Role of Bronchodilators in the LongTerm Maintenance Treatment of Patients
with COPD: A Review of the Data
Discover the mist. A dynamic presentation
of the role of bronchodilators in the longterm maintenance treatment of patients with
COPD. An expert speaker will review the
efficacy and safety data of bronchodilator
maintenance treatments as well as the features
of the inhaler.
Company: Boehringer Ingelheim
Pharmaceuticals, Inc.
1 to 1:45 p.m.
Industry Theater 1
Are We Gaining the Maximum Benefit
from Bronchodilators in COPD?
(Open to non-U.S. based physicians only)
During this industry theater supported by
Novartis, Chairman Ken Chapman will pose
pertinent clinical questions on COPD therapies to a faculty of world-renowned experts.
The program will highlight the fundamental
role of bronchodilators in COPD management, and will discuss key data on indacaterol
and glycopyrronium, as well as the efficacy
and safety profile of the dual bronchodilation
combination indacaterol/glycopyrronium.
Inhaled corticosteroids (ICS) have been
used in COPD management for many years
but their use in practice is often contrary to
guideline recommendations. New and recent
evidence— demonstrating that, for many
patients, effective bronchodilation may be a
better option than ICS-containing regimens—
will be shown. The appropriate ICS patient,
data from recent ICS withdrawal trials, and
use of alternative agents will be discussed.
Speakers: Chair: Professor Ken Chapman,
University of Toronto, Canada; Effective Use
of Bronchodilators in COPD; Professor José
Jardim, Federal University of São Paulo,
Brazil; Re-thinking the Use of ICS in COPD;
and Professor Marc Miravitlles, Hospital
Universitari Vall d’Hebron, Barcelona, Spain
Company: Novartis Pharma AG
11:45 a.m. to 12:30 p.m.
Industry Theater 2
Want to Add More to Your PAH Treatment
Strategy?
Join a panel of experts for a poster-themed
discussion on disease progression in pulmonary arterial hypertension, adding prostacyclin class therapy in appropriate patients, and
how an inhaled prostacyclin-class therapy
may help. Topics include diagnosis, clinical
trial study design, efficacy, side effects, dosing,
and therapy management. Lunch provided.
Speakers: Steven Nathan, MD, FCCP,
Medical Director, Advanced Lung Disease
and Lung Transplant Programs, Inova Fairfax
Hospital, Falls Church, VA; Lynette Brown,
MD, PhD, Associate Director, Pulmonary
Hypertension Program, Intermountain Medical
Center, Murray, UT; and Glenna Traiger, RN,
MSN, CNS-BC, Pulmonary Hypertension
CNS, David Geffen School of Medicine at
UCLA, Los Angeles, CA.
Company: United Therapeutics Corporation
1 to 1:45 p.m.
Industry Theater 2
The Role of Nitric Oxide (NO) in the
Pathology of PAH (WHO Group 1) and
CTEPH (WHO Group 4)
Pulmonary arterial hypertension (PAH)
and chronic thromboembolic pulmonary
hypertension (CTEPH) are two different
forms of pulmonary hypertension, characterized by elevated pulmonary artery pressures
and increased pulmonary vascular resistance.
Impaired synthesis of endogenous nitric oxide
contributes to the pathology of both diseases.
PH experts will present and discuss a CTEPH
case and a PAH case that are typical of patients who may be encountered in practice.
Speakers: Nicholas S. Hill, MD, Professor
of Medicine, Chief, Pulmonary, Critical Care
and Sleep Division, Tufts University School
of Medicine, Boston, MA, and Nick H. Kim,
MD, Clinical Professor of Medicine, Director,
Pulmonary Vascular Medicine, University of
California San Diego School of Medicine San
Diego, CA
Company: Bayer HealthCare Pharmaceuticals
11:30 a.m. to Noon
Mini Industry Theater
Pattern Recognition and Identification of
Idiopathic Pulmonary Fibrosis (IPF)
Come explore a hands-on learning adventure,
presented by thought-leader experts on IPF.
This program features a uniquely designed,
high-impact visual exploration of IPF. Participants will also be invited to test their new
knowledge via polling questions interspersed
throughout the program.
Company: Genentech, Inc.
12:30 to 1 p.m.
1:30 to 2 p.m.
Come Join Us at the Industry Theater Presentation
TREATMENT of the
RESPIRATORY MANIFESTATIONS
of
SYMPTOMATIC
SARCOIDOSIS
This program will discuss sarcoidosis
and an FDA-approved treatment option.
TUESDAY, MAY 19
11:30 AM–12:00 PM
Speaker 1
Robert P. Baughman, MD
University of Cincinnati Medical Center
12:30 PM–1:00 PM
Speaker 2
Daniel Culver, DO
Cleveland Clinic
Location
ATS 2015 International Conference
Box lunches will be provided.
Sponsored by
An Industry Theater Presentation at the ATS 2015 International Conference.
This presentation is sponsored by Mallinckrodt Pharmaceuticals and is open to all ATS 2015 International Conference attendees.
Please Note: Attendance is restricted to US healthcare providers (HCPs) only. Spouses and guests are not permitted to attend. Additionally, Federal employees and HCPs licensed to practice in Minnesota and Vermont
are not permitted to attend this event. Mallinckrodt Pharmaceuticals, Inc., is required to report all payments or exchanges of value (eg, meals) in compliance with the Sunshine Act and state laws. Please keep in mind that
HCPs may only attend 1 Mallinckrodt event per conference.
This event is not CME accredited.
© 2015 Mallinckrodt. PM-01-13-1769 04/15 Printed in USA
30
ATS 2015: Here’s Looking at You
Gilead_ATS_Daily.indd 1
4/13/15 11:36 AM
Building Healthy
Communities
Our medicines and vaccines
help millions of people live
longer and healthier lives.
But in order to fully achieve our mission of helping people do more,
feel better and live longer, we need to go beyond discovering,
developing and delivering new medicines, vaccines and healthcare
products. That’s why we support innovative health and education
programs designed to bring sustainable, positive change in local
communities across America.
© 2001– 2014 GLAXOSMITHKLINE ALL RIGHTS RESERVED.
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daily bulletin - American Thoracic Society

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