At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week Multi-center, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of NVA237 in Stable COPD Patients
In Brief
A Phase 3 clinical trial evaluating NVA237 and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 432 participants across 59 sites.
Detailed 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.
Study Details
Timeline
Interventions
NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules
Placebo powder for inhalation in single-dose capsules (matching those for NVA237).