Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 590
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day arm 2: Inhaled formoterol fumarate 12 μg, twice per day

Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Formoterol Fumarate
Intervention descriptions: intervention 1: Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day intervention 2: Inhaled formoterol fumarate 12 μg, twice per day

Protocol document: