CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,066 enrolled
Drug / intervention
Glycopyrronium bromide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00929110
NCT00929110Phase 3Completed
CompareCT.gov

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

Novartis·interventional·Posted Jun 26, 2009·Updated Aug 17, 2012

In Brief

A Phase 3 clinical trial evaluating Glycopyrronium bromide, Placebo to glycopyrronium bromide, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,066 participants across 139 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.0 years ago

Interventions

Glycopyrronium bromidedrug

Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to glycopyrronium bromidedrug

Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Tiotropiumdrug

Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.