Forest Laboratories and Almirall say that positive results were observed in a Phase III trial with its treatment for chronic obstructive pulmonary disease (COPD). The ACCORD COPD 1 Phase III trial compared inhaled aclidinium bromide therapy (200 micrograms and 400 micrograms BID) with placebo.
The North American trial involved 561 patients and is the first of three Phase III studies investigating the BID administration of aclidinium in COPD patients. The results showed treatment with both doses of the long-acting, inhaled anticholinergic bronchodilator led to statistically significant improvements in morning trough FEV1 at week 12. Aclidinium bromide therapy also significantly improved peak FEV1, the trial’s secondary endpoint.
Almirall and Forest are jointly developing aclidinium bromide. Forest licensed U.S. rights to the drug from Almirall, which retains rights to the rest of the world. The companies expect results from the ongoing ACCORD COPD II and ATTAIN Phase III during the second half of 2010 or early 2011.