Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial
Lee SD et al. - Roflumilast, 500 μg once daily, improves pulmonary function in Asian patients with chronic obstructive pulmonary disease (COPD). The safety and tolerability of roflumilast in this population was similar to that in a Caucasian population.
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 endpoint was mean change in FEV1 from baseline to each postrandomization visit during the treatment period.
Other spirometric lung function measurements were evaluated as secondary endpoints.
COPD exacerbations were monitored.
Safety was assessed from clinical laboratory tests, vital signs, physical examination (including electrocardiogram) and monitoring of adverse events (AEs).
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 FEV1 (79 mL, P < 0.0001).
Other spirometry endpoints, including prebronchodilator FEV1, pre-and postbronchodilator FEV6, 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.
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