Previous smokers:

 Study Name:

NB19751A:  A double-blind, placebo-controlled efficacy (as assessed by post-bronchodilator FEV₁) and safety study of 5 mg RO3300074 once-daily for 2 years in subjects with smoking related, moderate-to-severe COPD with emphysema receiving concurrent optimal COPD drug therapy

Sponsor: Hoffmann-La Roche Inc.

Primary objective:Previous smokers

 To investigate the efficacy, safety and tolerability of 5 mg/day study drug vs. placebo where all subjects are treated with optimal COPD drug therapy.

The sponsor proposes in this study to use a selective retinoid agonist for the treatment of smoking-related COPD with emphysema and to assess the potential disease-modifying effect of the study drug in humans. The proposed actions of the drug include tissue repair processes in the lung of patients with smoking-related emphysema.  Previous studies in animals and humans have provided the necessary background of safety information to now allow progressing to a 'proof of concept' safety and efficacy study in subjects with smoking-related COPD with emphysema.   

Study duration is 2 years long, and are seeking male and females over the age of 45, with a smoking history.  Subjects must be non-smoking for at least 1 year prior to study enrollment. 2 of every 3 subjects will receive active study drug while1 of every 3 subjects will receive the placebo (sugar pill).   All study subjects will be provided optimal therapy for their emphysema while they are enrolled in the study. Optimal therapy may include Spiriva, Advair, and or Symbicort.  Study procedures include: breathing tests, laboratory tests, and x-rays.