Phase 2b and 3 studies of aclidinium bromide for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD)

Almirall and Forest Laboratories announced positive top-line results from its Phase 3 study of inhaled aclidinium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This study, known as the ATTAIN study, was a 6 month double-blind placebo-controlled pivotal trial comparing the efficacy and safety of inhaled aclidinium bromide 200μg and 400μg twice daily versus placebo, in 828 patients. Aclidinium 200µg and 400µg produced statistically significant increases from baseline in morning pre-dose (trough) FEV1 versus placebo at week 12 (77mL and 105mL, respectively; p≤0.0001) which was the primary endpoint for the US. All secondary endpoints demonstrated statistically significant differences vs. placebo for both doses. These endpoints included peak FEV1, and the percentage of patients achieving a clinically meaningful reduction in breathlessness (assessed by a 1 unit improvement in Transition Dyspnea Index) and the percentage of patients with improved health status (assessed by a 4-unit improvement in the St. George's Respiratory Questionnaire).

Additionally, two Phase 2b dose-ranging studies comparing fixed-dose combinations (aclidinium bromide / formoterol) to aclidinium bromide alone, formoterol alone and placebo, administered twice daily in patients, have also been successfully completed. Both studies showed statistically significant (p<0.001) differences for the fixed dose combination on the primary endpoint versus placebo (normalized AUC 0-12 hours FEV1).

Aclidinium bromide is a long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors.

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