Conditions: Chronic Obstructive Pulmonary Disease COPD
Allocation:  | Intervention model: CROSSOVER
Enrollment: 88
Healthy volunteers: no

Brief summary:
The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

Detailed description:

Arms:
arm 1: QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 arm 2: Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

Interventions: intervention 1: QVA149 intervention 2: Tiotropium
Intervention descriptions: intervention 1: QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day intervention 2: Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Protocol document: