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: 291
Healthy volunteers: no

Brief summary:
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Detailed description:

Arms:
arm 1: Aclidinium bromide dose, inhaled, for 52 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Interventions: intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide
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: