Efficacy of roflumilast in former and current smokers with COPD

Background/Rationale: A history of smoking is common in COPD pts. Pooled data from four 1-year studies of the selective phosphodiesterase 4 inhibitor roflumilast (ROF) were analysed to investigate the effects of smoking history on response to ROF. Methods: Two studies enrolled pts with severe COPD associated with chronic bronchitis and a history of exacerbations and two studies enrolled pts with or without bronchitis and exacerbations. Following a 4-week placebo run-in, pts received ROF 500μg or placebo (PBO) for 52 wks. Primary endpoints were change in exacerbation rate and FEV1. We performed an analysis of these results according to smoking status. Results: Mean age (SD) was 64.13 (9.17) yrs; 3440 (59.5%) pts were former smokers and 2337 (40.5%) pts were current smokers. View this table: Table 1 Conclusions: The efficacy of ROF vs PBO in reducing the rate of moderate or severe exacerbations and improving pre- and post-BD FEV1 in pts with established COPD was independent of smoking history.