CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
QVA149 +3 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/NCT02487498
NCT02487498Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.

Novartis Pharmaceuticals·interventional·Posted Jul 1, 2015·Updated Apr 2, 2018

In Brief

A Phase 3 clinical trial evaluating QVA149, Umeclidinium/vilanterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 355 participants across 53 sites.

Detailed Summary

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartJul 27, 2015
Primary CompletionSep 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.0 years ago

Interventions

QVA149drug

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Umeclidinium/vilanteroldrug

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (umeclidinium/vilanterol )drug

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (QVA149)drug

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI