Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD chronic obstructive pulmonary disease indacaterol long acting β2-agonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 347
Healthy volunteers: no

Brief summary:
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Detailed description:

Arms:
arm 1: Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Interventions: intervention 1: Indacaterol 150 μg capsules intervention 2: Indacaterol 300 μg capsules intervention 3: Placebo capsules
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Protocol document: