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: PARALLEL
Enrollment: 605
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

Detailed description:

Arms:
arm 1: aclidinium bromide, inhaled, 52 weeks of treatment arm 2: aclidinium bromide, inhaled, 52 weeks of treatment

Interventions: intervention 1: Aclidinium Bromide 200 µg intervention 2: Aclidinium Bromide 400 µg
Intervention descriptions: intervention 1: aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment intervention 2: aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Protocol document: