Current Research Trials - Allergy & Asthma Clinic of Georgia

Current Research Trials
Georgia Pollens Clinical Research Centers, Inc.
105 Spanish Court, Albany, Georgia 31707
Telephone: 229-883-8909 Fax: 229-317-0609
D2210C00007 (STRATOS 1; drug, Tralokinumab) Ages 12-75 years of age with
medium-to-high dose ICS for at least 6 of the 12 months prior to enrolment (total daily dose ≥500μg fluticasone
propionate via dry powder inhaler or equivalent delivered dose) and with pre-BD FEV1 value of ≥40 and <80%
value. At least 2 documented asthma exacerbations in the 12 months prior. Length of trial: 50 weeks
placebo-controlled with a 16 week follow-up phase and for adolescents, 108 weeks placebo-controlled with a
16 week follow-up phase. Participants are seen every 2 weeks after randomization.
Compensation to participants: $50 after each completed visit.
Genentech-- WB28183: ACOUSTICS (Lebrikizumab)—Ages 12 – 17 years, with asthma diagnosis of > 12
months; uncontrolled asthma who are on inhaled corticosteroids and a second controller medication > 500 mcg
fluticasone daily for > 6 months and on a stable dose with no changes for a minimum of 4 weeks. No steroid
use within 4 weeks of screening visit. Tobacco use of < 10 pack years. No significant lung disease other than
asthma. Must have VEF1 within 40-90% at visits 2 & 3 and an ACQ score of > 1.5 at visit 1, 2 & 3.
(1 year placebo control followed by 1 year of active drug and then 6 months of follow-up)
Compensation to participants: $75 after each completed visit.
GlaxoSmithKline—EVA-14319 (Evidera) Ages 12 years and older with Severe Eosinophilic Asthma. Must
have peripheral blood eosinophil level of ≥150/μL that was related to asthma in the past 1 month or ≥300/μL in
the past 12 months, FEV1 < 80% and previously confirmed history of two or more asthma exacerbations
requiring treatment with oral or systemic corticosteroids in the previous 12 months.
Compensation to participants: $100 American Express gift check following a ONE TIME 60-90 minute
one-on-one interviews.
GlaxoSmithKline—201378 (Furoate/Vilanterol 100/25 mcg) Ages 12 years and older on a mid dose ICS
plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers)
for at least the 12 weeks immediately preceding Visit 1. A washout period of one week will be performed to
reduce the participant to ICS only. Pre-bronchodilator FEV1 of ≥80% predicted. Length of trial is 26 weeks
after randomization. Visits will be conducted late afternoons to allow for dosing after 5 PM.
Compensation to participants: $50 after each completed visit.
Novartis CFOR258D2416 (FDA mandated LABA safety trial) Ages 12 years and older with a > 1 year
history of persistent asthma and a recent asthma exacerbation between 30 days and 12
months prior to randomization and FEV1 > 50%. Tobacco use of < 10 pack years. (Study 26 weeks in
length)
Compensation to participants: $50 after each completed visit.
PEER--children between 2 and 17 years of age with eczema (atopic dermatitis) who have used Elidel cream
for the treatment of their disease. There is an initial Enrollment survey (which takes about 10 minutes) and
Authorization form to determine eligibility, and once enrolled, 2 surveys each year (one survey every 6
months). 10-year observation period
Compensation: $25 gift card mailed directly from the sponsor for each completed survey.
Roche WB28182 VOCALS ( Lebrikizumab) Ages 12-75 years of age with severe corticosteroid dependent
asthma and on high-dose ICS > 1500 mcg beclomethasone or equivalent for a minimum of 3 months and
chronic OCS at least 6 months at a dose of > 5 mg/daily and > 1 steroid boost to treat exacerbation within
the previous 12 months. FEV1 > 40%. Tobacco use of < 10 pack years. ACQ 7 > 1.25 (Study is a 44-week
placebo-controlled period with an OCS reduction phase at week 12 followed by a 32-week active treatment
with a 20-week safety follow-up at the completion of the active treatment phase)
Compensation to participants: $75 after each completed visit.