Almirall has completed a short-term phase II study comparing aclidinium twice daily (BID) vs tiotropium and placebo and has also completed the enrollment of a larger phase III three-month study with two different BID doses of Eklira vs placebo in patients with moderate to severe COPD.
Both studies will investigate the effects of aclidinium bromide in patients with moderate to severe COPD using a BID dosing regimen.
The primary endpoint of the short term double-blind, three-way cross-over, phase II study was to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide BID vs tiotropium and placebo in moderate to severe COPD patients. The primary outcome measure is change from baseline in FEV1 at day 15 of the treatment.
The primary objective of the phase III studies is to assess the efficacy and safety of aclidinium bromide compared to placebo in the treatment of moderate to severe COPD. These three-month and six-month studies have a two-week run-in period and a two-week follow-up visit, and the treatment duration will be of 12 and 24 weeks respectively. All patients meeting the eligibility criteria are randomised to either aclidinium doses or placebo. The primary endpoint will be morning pre-dose FEV1 in all dose regimens. The program also includes trials to assess long term safety of Eklira BID.
Per-Olof Andersson, executive director of R&D at Almirall, said: “The positive outcomes from a short-term phase II comparative study with Eklira BID vs tiotropium and placebo1, confirm Almirall and Forest decision to add to the ongoing twice daily development programme new phase III clinical studies, including one of three months and one of six months duration with aclidinium vs placebo.”
Almirall and Forest Laboratories plan to disclose the results of both the short-term comparative phase II study and the ongoing three-month phase III study in the first quarter of 2010.