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: 776
Healthy volunteers: no

Brief summary:
This study is a post-authorization commitment to the European Medicines Agency (EMA). 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 was tested for twice daily dosing against once daily dosing.

Detailed description:

Arms:
arm 1: Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine. arm 2: Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.

Interventions: intervention 1: NVA237 intervention 2: Placebo intervention 3: Salbutamol
Intervention descriptions: intervention 1: NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1 intervention 2: Placebo to NVA237 intervention 3: All patients received salbutamol (100 μg) as only rescue medication

Protocol document: