drugset / Trial / NCT01120691

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

NCT01120691 ↗

Phase 3 Completed 2224 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2010-04
Primary completion
2012-07
Completion
2012-07

Outcome

Met primary endpoint

paper QVA149 significantly reduced the rate of moderate to severe exacerbations versus glycopyrronium by 12% PMID 24429126 ↗

paper rate ratio 0·88, 95% CI 0·77-0·99, p=0·038 PMID 24429126 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glycopyrronium Unknown 50 ug Inhaled
Subject Indacaterol Other / unclassified 110 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled
Background Salbutamol Unknown — —