drugset / Trial / NCT03158311

Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium

NCT03158311

Phase 3 Completed 1426 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients. The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.

Timeline

Start
2018-02-05
Primary completion
2019-07-12
Completion
2019-07-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 500 ug Inhaled
Subject Glycopyrronium Unknown 50 ug Inhaled
Subject Indacaterol Other / unclassified 150 ug Inhaled
Subject Mometasone Other / unclassified 80 ug Inhaled
Subject Mometasone Other / unclassified 160 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled
Comparator Tiotropium Other / unclassified 5 ug Inhaled

Indications