Conditions: COPD
Keywords: COPD adults β2-agonist indacaterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 415
Healthy volunteers: no

Brief summary:
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Detailed description:

Arms:
arm 1: Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Placebo once-daily (o.d.) via SDDPI.

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Interventions: intervention 1: Indacaterol intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI) intervention 2: Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Protocol document: