NCT00929110

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,066 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Glycopyrronium bromide	Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
DRUG	Placebo to glycopyrronium bromide	Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
DRUG	Tiotropium	Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-06-26
• Last updated: 2012-08-17
• Results posted: 2012-07-27

Locations

139 sites across 16 countries: United States, Argentina, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, South Korea