Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Anticholinergic Antimuscarinic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease Chronic Obstructive Pulmonary Disease COPD LAMA Lung Disease Lung Diseases, Obstructive Lung Function Muscarinic receptor antagonist Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 440
Healthy volunteers: no

Brief summary:
The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment.

The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Detailed description:

Arms:
arm 1: NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks arm 2: Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.

Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules. intervention 2: Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Protocol document: