CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 523 enrolled
Drug / intervention
indacaterol and glycopyrronium (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/NCT01315249
NCT01315249Phase 3Completed
CompareCT.gov

A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals·interventional·Posted Mar 15, 2011·Updated Aug 9, 2013

In Brief

A Phase 3 clinical trial evaluating indacaterol and glycopyrronium (QVA149), Placebo to fluticasone/salmeterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 523 participants across 93 sites in 9 countries.

Detailed Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesBelgium, Czechia, Estonia, Germany, Hungary, Lithuania, Norway, South Korea, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2011
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago

Interventions

indacaterol and glycopyrronium (QVA149)drug

QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.

Placebo to fluticasone/salmeteroldrug

Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.

fluticasone/salmeteroldrug

Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.

Placebo to indacaterol and glycopyrronium (QVA149)drug

Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily