Abstract
Background/Rationale: Roflumilast (ROF) is the first oral, selective phosphodiesterase 4 inhibitor licensed for the treatment of severe COPD associated with chronic bronchitis and a history of frequent exacerbations. This study (NCT00242320) examined the efficacy, safety and tolerability of ROF in Asian patients with COPD.
Methods: Patients with moderate to severe COPD (post-bronchodilator FEV1 30–80% predicted) were recruited from 32 outpatient centres in Hong Kong, Malaysia, the Philippines, South Korea and Taiwan. Patients were randomly assigned (1:1) to oral ROF, 500μg once daily, or placebo, in a 12-week treatment period, following a single-blind baseline period in which all patients received placebo for 4 weeks. The primary endpoint was mean change in post-bronchodilator FEV1 from baseline to each post-randomisation visit. Safety endpoints included clinical laboratory tests, vital signs, physical examination (including electrocardiogram) and monitoring of adverse events (AEs).
Results: Of 551 patients recruited, 410 were randomised and treated (ROF, n=203; placebo, n=207). ROF improved post-bronchodilator FEV1 by 79mL vs placebo (p<0.0001) at final scheduled visit. Pre-bronchodilator FEV1, pre-and post-bronchodilator FEV6, forced vital capacity and peak expiratory flow also significantly favoured ROF over placebo. In both groups, >90% patients completed treatment without exacerbations. AEs were more common with ROF than placebo, but were comparable with those in previous studies.
Conclusions: ROF, 500μg once daily, improves lung function in Asian patients with COPD. The safety and tolerability of ROF was similar to that observed in a Caucasian population.
- © 2011 ERS