TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
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This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.
A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.
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Ages Eligible for Study:
44 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients of >44 years of age, with >10 pack-year smoking history;
women not of child-bearing potential;
ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema;
willing to be switched to optimal COPD therapy.
off oral steroids >28 days prior to enrollment;
>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening;
exposure to synthetic oral retinoids in past 12 months;