Conditions: Chronic Obstructive Pulmonary Disease
Keywords: indacaterol chronic obstructive pulmonary disease exercise endurance moderate to severe chronic obstructive pulmonary disease COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 90
Healthy volunteers: no

Brief summary:
This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.

Detailed description:

Arms:
arm 1: Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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 first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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 300 μg intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Protocol document: