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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
491
Post-bronchodilator FEVI
Time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
Time frame: At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.
Time frame: Thoughout study
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