CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 744 enrolled
Drug / intervention
QVA149 +3 moredrug
Likely dose
QVA149 50 µgfrom 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/NCT01709903
NCT01709903Phase 3Completed
CompareCT.gov

A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy and Safety of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe COPD

Novartis Pharmaceuticals·interventional·Posted Oct 18, 2012·Updated Mar 17, 2015

In Brief

A Phase 3 clinical trial evaluating QVA149, Fluticasone/salmeterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 744 participants across 55 sites in 4 countries.

Detailed Summary

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Chile, China, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.7 years ago

Interventions

QVA149drug

QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI).

Fluticasone/salmeteroldrug

Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device.

Placebo to QVA149drug

Placebo to QVA149 with SDDPI

Placebo to fluticasone/salmeteroldrug

Placebo to fluticasone/salmeterol with Accuhaler