Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Indacaterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 318
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. arm 2: Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Interventions: intervention 1: Indacaterol intervention 2: Placebo to indacaterol
Intervention descriptions: intervention 1: Once daily via single-dose dry powder inhaler (SDDPI) intervention 2: Once daily via SDDPI

Protocol document: