In the trial, the improvement in FEV1, the primary endpoint, was prominent in the 200ug (p=0.019) and 400ug (p=0.001) BID dose groups.
However, for the expected therapeutic dose, 400ug, the magnitude of effect compared to placebo, 72ml, was less than that observed in three other studies.
Forest Laboratories and Almirall claimed that Aclidinium was well tolerated in the trial with a profile that was consistent with prior studies.
In addition, a third double-blind placebo controlled trial (ATTAIN) of the 400ug BID aclidinium dose of six months duration assessing efficacy and safety in patients with COPD is currently underway with results from that study expected to be available in 1Q 2011.
The ATTAIN study, if positive, along with the previously reported ACCORD COPD I Phase III trial of aclidinium BID, will serve as the core for the monotherapy US NDA and EU filings anticipated in mid-2011.
Forest Laboratories president and chief operating officer Lawrence Olanoff said that they remain confident that the ongoing Phase III ATTAIN trial will confirm a clinical effect of aclidinium BID similar to that as reported in January of this year for the ACCORD COPD I trial and the Phase II comparison studies.