Almirall and Forest said that Aclidinium was well tolerated in the study and all secondary endpoints demonstrated differences vs placebo for both doses.
The Phase III double-blind placebo-controlled pivotal trial compared the safety and efficacy of Aclidinium Bromide 200µg and 400µg twice daily (BID) versus placebo, in 828 patients with moderate to severe COPD.
In the study, Aclidinium showed changes from baseline in trough FEV1 vs placebo at each time-point, which ranged from 77ml to 105ml for Aclidinium 200µg and from 105ml to 140ml for Aclidinium 400µg.
Almirall chairman and CEO Jorge Gallardo said that the results demonstrate that Aclidinium provided consistent bronchodilation and symptom control in COPD patients suffering from this debilitating disease.
"With these results, we anticipate regulatory filings for Aclidinium BID monotherapy this year," Gallardo said.