CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 500 enrolled
Drug / intervention
QVA149 110/50 micrograms +1 moredrug
Likely dose
QVA149 110/50 microgramsfrom 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/NCT02516592
NCT02516592Phase 4Completed
CompareCT.gov

A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients

Novartis Pharmaceuticals·interventional·Posted Aug 6, 2015·Updated Mar 21, 2019

In Brief

A Phase 4 clinical trial evaluating QVA149 110/50 micrograms and Salmeterol/fluticasone 50/500 microgrammes for COPD. Completed, enrolled 500 participants across 64 sites in 11 countries.

Detailed Summary

This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesAustralia, Egypt, India, Israel, Lebanon, Malaysia, Philippines, Saudi Arabia, South Africa, Taiwan, Turkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 6, 2015
Enrollment StartOct 13, 2015
Primary CompletionMay 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.9 years ago

Interventions

QVA149 110/50 microgramsdrug

QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)

Salmeterol/fluticasone 50/500 microgrammesdrug

Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device