Aclidinium bromide: Phase III data

Top-line data from the double-blind, North American Phase III ACCORD COPD II trial in 544 patients with moderate to severe COPD showed that 200 and 400 µg twice-daily aclidinium met the primary endpoint of significantly improving morning trough FEV1 from baseline to week 12 vs. placebo (p=0.019 and p=0.001, respectively). However, the partners said the magnitude of effect for the expected therapeutic dose of 400 µg aclidinium, which produced a 72 mL improvement in FEV1 compared to placebo, was less than that observed in 3 previous studies of the compound, including the similar Phase III ACCORD COPD I trial. Further analyses of the trial are ongoing. Aclidinium was well tolerated. ...