CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 379 enrolled
Drug / intervention
Indacaterol and glycopyrronium (QVA149) +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/NCT02566031
NCT02566031Phase 4Completed
CompareCT.gov

A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

Novartis Pharmaceuticals·interventional·Posted Oct 1, 2015·Updated Sep 23, 2019

In Brief

A Phase 4 clinical trial evaluating Indacaterol and glycopyrronium (QVA149) and Tiotropium for COPD. Completed, enrolled 379 participants across 24 sites.

Detailed Summary

To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartMar 23, 2013
Primary CompletionJun 4, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.8 years ago

Interventions

Indacaterol and glycopyrronium (QVA149)drug

Capsules for inhalation delivered via SDDPI

Tiotropiumdrug

Capsules for inhalation delivered via HandiHaler® device