The study results included data from a 464-patient randomized, double-blind, four-week, Phase IIb study that evaluated both the efficacy and tolerability of once-daily aclidinium (25mcg, 50mcg, 100mcg, 200mcg or 400mcg) or placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). An open-label tiotropium (18mcg) arm was included as an active control.
The study demonstrated aclidinium (200mcg and 400mcg), administered via a multi-dose dry powder inhaler, significantly increased trough (24 hour) forced expiratory volume in one second (FEV1) – an important measure of lung function – on day 29 compared with placebo (p<0.05 versus placebo). There was a dose response observed for lung function improvement with once-daily aclidinium. Aclidinium was well-tolerated, with no dose-dependent effect on ECG, laboratory parameters, or adverse events. Based on these results, aclidinium 200mcg administered once every 24 hours was selected as the dose for investigation in the two ongoing Phase III clinical trials, Acclaim COPD I and II, which are expected to report out during the second half of 2008.