Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 154
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 2: Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. arm 3: One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 4: Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Interventions: intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: placebo
Intervention descriptions: intervention 1: Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 2: Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 3: Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Protocol document: