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Investigating the Effects of QVM149 on MRI Ventilation Defects

NCT04206761 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-12-14

No results posted yet for this study

Summary

The purpose of this study is to compare treatment with QVM149, an inhaler that contains three types of asthma medications compared to an inhaler that contains two types of asthma medications. Both inhalers contain an inhaled corticosteroid, which reduces inflammation in the lungs, and a medication that helps to open up the airways. The investigational inhaler, QVM149, contains a third medication that also works to open up the airways. The investigators will measure the difference in these two treatments with magnetic resonance imaging (MRI) using a special technique using xenon gas to show how gas spreads in the lungs. In healthy lungs, the gas fills the lungs evenly, but in unhealthy lungs, the gas may fill the lungs unevenly and they will appear patchy. The patchy areas are called ventilation defects. A CT of the chest will be done to assess the structure of the lungs. The investigators will also use lung function testing and questionnaires to evaluate the differences between these therapies.

Conditions

Interventions

DRUG

QVM149

QVM149 is an investigational drug consisting of 150μg indacaterol acetate, 50μg glycopyrronium bromide and 160μg mometasone furoate. The drug is delivered as powder in hard capsules via Breezhaler, a breath-activated device which will deliver a specific dose of medication

DRUG

High Dose Dual Therapy (ICS/LABA)

High dose inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) in any approved drug formulation and delivery device.

Sponsors & Collaborators

Principal Investigators

  • Grace E Parraga, PhD · Robarts Research Institute, The University of Western Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-07-01
Completion
2022-12-01

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206761 on ClinicalTrials.gov