A multi-institution study has found Roflumilast to provide a major boost to lung function when compared to placebo in moderate and severe chronic obstructive pulmonary disease (COPD) patients six months after treatment.
Roflumilast is approved to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. To examine the drug's impact on lung function, researchers from multiple institutions, including Baylor College of Medicine; Takeda Pharmaceuticals International GmbH; and Forest Research Institute, randomized 4,746 subjects to roflumilast (pooled intent-to-treat [ITT], n= 2511; moderate COPD, n=1184; severe COPD, n=1217) or placebo (pooled ITT, n=2235; moderate COPD, n=1098; severe COPD, n=1062). Baseline demographics were similar between treatment groups. At 6 months, roflumilast increased pre- and postbronchodilator FEV1 by 66 mL and 67 mL, respectively, compared with placebo. Roflumilast, compared with placebo, also increased pre- and postbronchodilator FEV1 in subjects with moderate and severe COPD. This study was presented during CHEST 2012, the annual meeting of the American College of Chest Physicians, held October 20 - 25, in Atlanta, Georgia.