Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 267
Healthy volunteers: no

Brief summary:
The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.

Detailed description:

Arms:
arm 1: 8 weeks, double blind treatment period arm 2: 8 weeks, double blind treatment period

Interventions: intervention 1: Aclidinium/Formoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler intervention 2: Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler

Protocol document: