drugset / Trial / NCT02371629

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

NCT02371629

Phase 4 Completed 776 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrrolate Small molecule 22 ug Inhaled
Subject Glycopyrrolate Small molecule 44 ug Inhaled
Background Salbutamol Unknown 100 ug