Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Pulmonary Disease Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease COPD COAD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 156
Healthy volunteers: no

Brief summary:
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening arm 2: Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening arm 3: Formoterol fumarate 12 µg twice-daily (BID)

Interventions: intervention 1: Once-daily aclidinium/formoterol intervention 2: Twice-daily formoterol fumarate intervention 3: Placebo to formoterol fumarate intervention 4: Once-daily formoterol fumarate
Intervention descriptions: intervention 1: Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning intervention 2: Inhaled formoterol fumarate 12 µg twice-daily (BID) intervention 3: Inhaled placebo to formoterol fumarate once-daily in the evening intervention 4: Inhaled formoterol fumarate 12 μg once-daily in the evening

Protocol document: