ABSTRACT
Aclidinium bromide is a novel, long-acting, inhaled
muscarinic antagonist in development for the treatment of
chronic obstructive pulmonary disease (
COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and
tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in
COPD patients with a post-
bronchodilator forced expiratory volume in 1 second (FEV(1)) ≥30% and <60% predicted. On study days, patients received single doses of aclidinium 200 μg,
tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV(1) of ≥10% above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV(1) and
dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV(1) of ≥10% above baseline at 30 minutes with aclidinium and
tiotropium versus placebo (49.5% and 51.8% versus 13.8%; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV(1) was significantly higher for aclidinium and
tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and
tiotropium also significantly increased FEV(1) (p < 0.01) and improved the perception of
dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with
tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.