Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD indacaterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief summary:
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Detailed description:

Arms:
arm 1: Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 75 μg intervention 2: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Protocol document: