drugset / Trial / NCT01709903

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

NCT01709903

Phase 3 Completed 744 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

Timeline

Start
2012-11
Primary completion
2014-02
Completion
2014-02

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