drugset / Trial / NCT01315249

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01315249 ↗

Phase 3 Completed 523 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Timeline

Start
2011-03
Primary completion
2012-03
Completion
2012-03

Outcome

Met primary endpoint

paper At week 26, FEV1 AUC0-12h was significantly higher with QVA149 than with SFC (treatment difference 0·138 L; 95% CI 0·100-0·176; p<0·0001). PMID 24321804 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 500 ug Inhaled
Subject Glycopyrronium Unknown 50 ug Inhaled
Subject Indacaterol Other / unclassified 110 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled