Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD QVA149 nocturnal oxygen levels combination bronchodilator
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.

Detailed description:

Arms:
arm 1: Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day. arm 2: Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.

Interventions: intervention 1: QVA149 intervention 2: QVA149 Placebo
Intervention descriptions: intervention 1: Delivered once daily via single-dose dry powder inhaler intervention 2: Placebo delivered once daily via single-dose dry powder inhaler

Protocol document: