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: 561
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Detailed description:

Arms:
arm 1: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 3: Inhaled placebo for 12 weeks

Interventions: intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide intervention 3: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment intervention 2: Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment intervention 3: Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Protocol document: