Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease antimuscarinic COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 828
Healthy volunteers: no

Brief summary:
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Detailed description:

Arms:
arm 1: Aclidinium bromide 200 μg twice-daily via inhalation arm 2: Aclidinium bromide 400 μg twice-daily via inhalation arm 3: Placebo

Interventions: intervention 1: Aclidinium bromide 200 μg bid intervention 2: Aclidinium bromide 400 μg bid intervention 3: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 2: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 3: Placebo twice-daily by inhalation for 24 weeks

Protocol document: