Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Indacaterol Maleate, Exercise testing
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 27
Healthy volunteers: no

Brief summary:
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients

Detailed description:

Arms:
arm 1: In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. arm 2: In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

Interventions: intervention 1: Indacaterol 300μg intervention 2: Placebo
Intervention descriptions: intervention 1: 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device intervention 2: Matching placebo devices and hard gelatin capsules

Protocol document: