Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Bronchitis Chronic Emphysema
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 176
Healthy volunteers: no

Brief summary:
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Detailed description:

Arms:
arm 1: Formoterol fumarate 12 μg twice daily arm 2: Placebo twice daily arm 3: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily arm 4: Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily arm 5: Aclidinium bromide 200 μg twice daily

Interventions: intervention 1: Aclidinium 200 μg / formoterol 12 μg intervention 2: Placebo intervention 3: Formoterol 12 μg intervention 4: Aclidinium 200 μg intervention 5: Aclidinium 200 μg / Formoterol 6 μg
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily intervention 2: Placebo control twice daily intervention 3: Formoterol fumarate 12 μg twice daily intervention 4: Aclidinium bromide 200 μg twice daily intervention 5: Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Protocol document: