Abstract
The efficacy and safety of two doses of aclidinium bromide were evaluated in patients with moderate to severe COPD.
In this 24-week, double-blind trial, patients were randomised to twice-daily aclidinium (200 μg or 400 μg) or placebo. The primary efficacy endpoint was change in trough forced expiratory volume in 1 second (FEV1) at Week 24. Other endpoints included peak FEV1, health status (St George's Respiratory Questionnaire; SGRQ) and dyspnoea (Transitional Dyspnoea Index; TDI).
Overall, 828 patients were randomised. At Week 24, significant improvements from baseline were observed with aclidinium 200 μg and 400 μg versus placebo for trough FEV1 (99 and 128 mL; both p<0.0001) and peak FEV1 (185 and 209 mL; both p<0.0001). Peak FEV1 improvements on Day 1 were comparable with Week 24. Aclidinium 200 μg and 400 μg produced significant improvements over placebo in baseline-adjusted mean SGRQ total score (−3.8 and −4.6 units; p<0.001 and <0.0001) and TDI focal score (0.6 and 1.0 units; p<0.05 and <0.001) at Week 24. With both aclidinium doses, the incidence of anticholinergic adverse events was low and similar to placebo.
Twice-daily aclidinium significantly improved bronchodilation, health status and dyspnoea, and was well tolerated in patients with COPD.
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