Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 128
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.

Detailed description:

Arms:
arm 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) arm 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) arm 3: Aclidinium bromide 400 μg administered twice-daily (BID) arm 4: Formoterol fumarate 12 μg twice-daily arm 5: Placebo twice-daily

Interventions: intervention 1: Aclidinium 400 μg / Formoterol 12 μg intervention 2: Aclidinium 400 μg / Formoterol 6 μg intervention 3: Aclidinium 400 μg intervention 4: Formoterol 12 μg intervention 5: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 3: Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 4: Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods. intervention 5: Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Protocol document: