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: 1692
Healthy volunteers: no

Brief summary:
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Detailed description:

Arms:
arm 1: Aclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg arm 2: Aclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg arm 3: Aclidinium monotherapy 400 μg arm 4: Formoterol monotherapy 12 μg arm 5: Placebo

Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Aclidinium Bromide/Formoterol Fumarate intervention 3: Aclidinium Bromide intervention 4: Formoterol Fumarate intervention 5: Placebo
Intervention descriptions: intervention 1: Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day intervention 2: Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day intervention 3: Inhaled Aclidinium 400 μg, twice per day intervention 4: Inhaled Formoterol 12 μg, twice per day intervention 5: Inhaled dose-matched placebo, twice per day

Protocol document: