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- W2128412912 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 FEV 1 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 FEV 1 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 FEV 1 by 79mL vs placebo (p 1 , pre-and post-bronchodilator FEV 6 , 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." @default.
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- W2128412912 date "2011-09-01" @default.
- W2128412912 modified "2023-09-24" @default.
- W2128412912 title "Roflumilast in Asian patients with COPD: A randomised placebo-controlled trial" @default.
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