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COPD Patients Benefit From Aclidinium/Formoterol in Phase III Study
Combo therapy more effective than either drug used alone (Apr. 16)
Positive results have been announced from a 6-month pivotal phase III trial that evaluated the efficacy and safety of fixed-dose combinations of inhaled aclidinium bromide and formoterol fumarate (Almirall S.A/Forest Laboratories) in patients with chronic obstructive pulmonary disease (COPD).
Both combinations of aclidinium/formoterol (400/6 mcg and 400/12 mcg given twice daily) demonstrated statistically significant improvements in the co-primary endpoints of the change from baseline in morning predose trough forced expiratory volume at 1 second (FEV1) versus formoterol 12 mcg and in FEV1 at 1 hour post-dose versus aclidinium 400 mcg at week 24 (P < 0.01 and P ≤ 0.0001, respectively). In addition, both combinations of aclidinium/formoterol provided statistically significant improvements versus placebo in these variables (both P < 0.0001).
The most common adverse events were nasopharyngitis (7.9% for 400/6 mcg and 7.8% for 400/12 mcg vs. 7.2% for placebo) and back pain (3.4% for 400/6 mcg and 4.7% for 400/12 vs. 4.6% for placebo).
Results from a second pivotal phase III trial are expected in the coming weeks. If the second study is successful, those results, combined with the positive results of the present study, will be used to support the filing of a new drug application (NDA) with the FDA.
The ACLIFORM/COPD (ACLIdinium/FORMoterol Fumarate Combination for Investigative Use in the Treatment of Moderate to Severe COPD) trial was a 24-week randomized double-blind study that evaluated 400/6 mcg and 400/12 mcg fixed-dose combinations of aclidinium bromide/formoterol fumarate compared with aclidinium bromide 400 mcg, formoterol fumarate 12 mcg, and placebo administered twice daily through the Pressair inhaler in 1,729 patients with moderate-to-severe COPD.
Aclidinium bromide is an anticholinergic or long-acting muscarinic antagonist (LAMA) that produces bronchodilation by inhibiting the muscarinic M3 receptor in airway smooth muscles. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates the B2-receptors in bronchial smooth muscles, resulting in bronchodilation. Both aclidinium bromide and formoterol fumarate are approved for the maintenance treatment of COPD in the U.S.
Source: Forest Laboratories; April 16, 2013.