Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Bronchitis Chronic Emphysema Smokers or ex-Smokers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 808
Healthy volunteers: no

Brief summary:
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Detailed description:
Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Aclidinium bromide and formoterol intervention 2: Aclidinium bromide and formoterol placebo
Intervention descriptions: intervention 1: once daily intervention 2: once daily

Protocol document: