Positive Results for Combination COPD Therapy

Almirall and Forest Laboratories announced positive results from a six-month pivotal Phase 3 clinical trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonist (LABA) delivered by Almirall's inhaler Pressair (Genuair in Europe).

Aclidinium bromide/formoterol fumarate is an investigational fixed dose combination of two approved long-acting bronchodilators. Aclidinium bromide is an anticholinergic or LAMA that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a LABA that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation.

ACLIFORM/COPD (ACLIdinium/FORMoterol fumarate combination for investigative use in the treatment of moderate to severe COPD) was a 24-week randomized double-blind trial evaluating the 400/6mcg and 400/12mcg fixed dose combinations of aclidinium bromide/formoterol fumarate compared with aclidinium bromide 400mcg, formoterol fumarate 12mcg and placebo administered twice daily through the Genuair/Pressair inhalers in 1,729 patients with moderate to severe COPD. The co-primary efficacy endpoints were change from baseline in morning pre-dose trough FEV1 vs. formoterol 12mcg and change from baseline in FEV1 at 1 hour post-dose vs. aclidinium 400mcg at week 24.

Both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg given twice a day) demonstrated statistically significant improvements in the co-primary endpoints (P<0.01 and P≤0.0001, respectively). In addition, both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg) provided statistically significant improvements vs. placebo in regards to the co-primary endpoints (both P<0.0001).

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