Background and objective: Roflumilast, an oral, selective phosphodiesterase 4 inhibitor, has been shown to reduce exacerbations and improve pulmonary function in patients with COPD. This study examined the efficacy, safety and tolerability of roflumilast in Asian patients with COPD. Methods: Patients with COPD were randomized 1:1 to enter a 12-week treatment period and receive either oral roflumilast, 500 μg once daily, or placebo, following a single-blind, 4-week baseline period in which all patients received placebo. The primary end point was mean change in FEV 1 from baseline to each postrandomization visit during the treatment period. Other spirometric lung function measurements were evaluated as secondary end points. COPD exacerbations were monitored. Safety was assessed from clinical laboratory tests, vital signs, physical examination (including electrocardiogram) and monitoring of adverse events (AEs). Results: Of 551 patients recruited, 410 were randomized and received at least one dose of study medication (roflumilast, n = 203; placebo, n = 207). Superiority of roflumilast over placebo was demonstrated by a statistically significant difference in postbronchodilator FEV 1 (79 mL, P < 0.0001). Other spirometry end points, including prebronchodilator FEV 1, pre-and postbronchodilator FEV 6, forced vital capacity and peak expiratory flow significantly favoured roflumilast over placebo. AEs were more common with roflumilast than with placebo, but were comparable with those reported in previous studies. Conclusions: Roflumilast, 500 μg once daily, improves pulmonary function in Asian patients with COPD. The safety and tolerability of roflumilast in this population was similar to that in a Caucasian population. Roflumilast (500 μg once daily for 12 weeks vs placebo) significantly improved lung function in Asian patients with moderate to severe COPD. Treatment was well tolerated, and no safety/tolerability issues specific to ethnicity were raised. These clinical findings add to those from previous studies of roflumilast in Caucasian patients.
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