CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 247 enrolled
Drug / intervention
QVA149 +4 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/NCT01490125
NCT01490125Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Novartis Pharmaceuticals·interventional·Posted Dec 12, 2011·Updated Dec 24, 2013

In Brief

A Phase 3 clinical trial evaluating QVA149, Tiotropium, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 247 participants across 43 sites in 5 countries.

Detailed Summary

This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBelgium, Canada, Germany, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.6 years ago

Interventions

QVA149drug

QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI

Tiotropiumdrug

Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Placebo to QVA149drug

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

Placebo to tiotropiumdrug

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Salbutamol/albuteroldrug

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.