CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,053 enrolled
Drug / intervention
QVA149 +2 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/NCT02603393
NCT02603393Phase 4Completed
CompareCT.gov

A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

Novartis Pharmaceuticals·interventional·Posted Nov 11, 2015·Updated Apr 29, 2019

In Brief

A Phase 4 clinical trial evaluating QVA149, Tiotropium, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,053 participants across 167 sites in 21 countries.

Detailed Summary

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesArgentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 11, 2015
Enrollment StartNov 20, 2015
Primary CompletionJul 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.6 years ago

Interventions

QVA149drug

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI

Tiotropiumdrug

Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®

Salmeterol/fluticasonedrug

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™