CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,426 enrolled
Drug / intervention
QVM149 +1 moredrug
Likely dose
Not stated in 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/NCT03158311
NCT03158311Phase 3Completed
CompareCT.gov

A Multicenter, Partially-Blinded, Randomized, 24-Week, Parallel-Group, Non-Inferiority, Open-Label Active Controlled Study to Compare the Efficacy and Safety of QVM149 With a Free Triple Combination of Salmeterol/Fluticasone + Tiotropium in Patients With Uncontrolled Asthma

Novartis Pharmaceuticals·interventional·Posted May 18, 2017·Updated Oct 8, 2021

In Brief

A Phase 3 clinical trial evaluating QVM149 and Salmeterol/fluticasone plus tiotropium for Asthma. Completed, enrolled 1,426 participants across 163 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Chile, Colombia, Czechia, Germany, Greece, Hungary, India, Israel, Mexico, Peru, Poland, Russia, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartFeb 5, 2018
Primary CompletionJul 12, 2019
Study CompletionJul 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago

Interventions

QVM149drug

Indacaterol acetate / glycopyrronium bromide / mometasone furoate

Salmeterol/fluticasone plus tiotropiumdrug

Free triple arm of salmeterol / fluticasone plus tiotropium