CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,224 enrolled
Drug / intervention
QVA149 +3 moredrug
Likely dose
QVA149 50 μgfrom 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/NCT01120691
NCT01120691Phase 3Completed
CompareCT.gov

A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Novartis Pharmaceuticals·interventional·Posted May 11, 2010·Updated Dec 2, 2013

In Brief

A Phase 3 clinical trial evaluating QVA149, NVA237, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 2,224 participants across 342 sites in 28 countries.

Detailed Summary

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Austria, Canada, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.1 years ago

Interventions

QVA149drug

QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

NVA237drug

NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

tiotropiumdrug

Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

Salbutamol/albuteroldrug

As needed throughout the study