Roflumilast was associated with significant improvements in lung function in patients with moderate and severe chronic obstructive pulmonary disease (COPD) after 6 months of treatment compared with placebo. 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.