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.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 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.