Forest Laboratories and Almirall announced positive top line results from AUGMENT COPD, the second six-month Phase 3 clinical trial evaluating the safety and efficacy of investigational fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) delivered in the Pressair inhaler.
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.
AUGMENT (Aclidinium/formoterol FUmurate Combination for InvestiGative use in the TreatMENT of Moderate to Severe COPD) was a 24-week, randomized, double-blind trial evaluating 400/12mcg and 400/6mcg fixed dose combinations of aclidinium bromide/formoterol fumarate compared with aclidinium bromide 400mcg, formoterol fumarate 12mcg, and placebo administered twice daily through the Pressair inhaler in 1,692 patients with moderate to severe COPD. The first co-primary endpoint was the comparison between the fixed dose combinations of aclidinium/formoterol 400/12mcg and 400/6mcg vs. aclidinium alone in change from baseline in FEV1 at 1 hour post-dose at week 24. The second co-primary endpoint was the comparison between the fixed dose combinations of aclidinium/formoterol 400/12mcg and 400/6mcg vs. formoterol alone in change from baseline in morning pre-dose trough FEV1 at week 24.
Aclidinium/formoterol 400/6mcg demonstrated statistically significant improvements in (FEV1) at 1 hour post-dose vs. aclidinium 400mcg (P<0.0001). The 400/12mcg combination of aclidinium/formoterol demonstrated statistically significant improvements in change from baseline for the co-primary endpoints of Forced Expiratory Volume (FEV1) at 1 hour post-dose vs. aclidinium 400mcg (P<0.0001) and morning predose trough FEV1 vs. formoterol 12mcg at week 24 (P<0.05). Both combinations of aclidinium/formoterol (400/12mcg and 400/6mcg) achieved statistically significant improvements vs. placebo in the above two comparisons (both P<0.0001).
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