Conditions: Chronic Obstructive Pulmonary Disease
Keywords: NVA237 COPD bronchodilator exercise endurance
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 108
Healthy volunteers: no

Brief summary:
The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study. arm 2: Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: 50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily intervention 2: Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Protocol document: