科研之友
微信
新浪微博
Facebook
分享链接
摘要
Aclidinium bromide is a novel, long-acting, muscarinic antagonist in phase III development for the maintenance treatment of COPD. This phase IIb study investigated the efficacy and safety of aclidinium for the treatment of moderate to severe COPD to establish the optimal dose for phase III studies. A total of 464 patients with moderate to severe stable COPD were randomised to double-blind, once-daily treatment with aclidinium (25, 50,100, 200, or 400 mu g), placebo, or open-label tiotropium (18 mu g) for 4 weeks. Spirometric measurements were performed at 22-24 h after the first dose and then at weekly intervals, and from 0.5 to 6 h post-dose on day 1 and day 29. Compared with placebo, aclidinium 200 mu g and 400 mu g significantly increased trough FEV1, on day 29 versus baseline. During the first 6 h post-dose, the bronchodilatory effect of aclidinium (all doses) on day I was comparable to that on day 29. Time to peak FEV1 was 3 h for aclidinium 100-400 mu g. Aclidinium was well tolerated, with no dose-dependent effect on ECG, laboratory parameters, or adverse events. The incidence of AEs was generally comparable to placebo. Aclidinium produced sustained bronchodilation over 24 It and was well tolerated during this short-term study. Based on these data, aclidinium 200 mu g was selected as the investigational dose for future clinical trials in COPD.
- 出版日期2010-2
