Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD indacaterol long-acting β2-agonist adults
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 563
Healthy volunteers: no

Brief summary:
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.

Detailed description:

Arms:
arm 1: Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 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 indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 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 3: Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 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 150 µg intervention 2: Indacaterol 300 μg intervention 3: Placebo to indacaterol
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 to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Protocol document: