RT Journal Article SR Electronic T1 Efficacy of roflumilast in former and current smokers with COPD JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP p247 VO 38 IS Suppl 55 A1 Peter Calverley A1 Udo-Michael Goehring A1 Fernando Martinez A1 Neil Barnes YR 2011 UL http://erj.ersjournals.com/content/38/Suppl_55/p247.abstract AB 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 1Conclusions: 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.