A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

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.

Timeline

Start

2015-06-24

Primary completion

2016-11-16

Completion

2016-11-16

Outcome

Missed primary endpoint

registry NVA237 Twice Daily vs NVA237 Once Daily; p = 0.051; Mean Difference (Net) 0.033 (95% CI 0.000 to 0.066) NCT02371629 ↗

Drugs

Indications