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129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation

NCT07192016 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-25

No results posted yet for this study

Summary

The goal of this study is to study how 12-weeks daily (and optional 48-weeks) single inhaler triple therapy (fluticasone furoate (FF)-an inhaled corticosteroid; umeclidinium (UMEC)-a long-acting muscarinic antagonist; vilanterol (VI)-a long-acting β2-adrenergic agonist) works to treat adults with COPD. The investigators will compare the effects of this medication on adults with COPD who are at low risk of a flare-up and adults with COPD who are at high risk of a flare-up. The main questions it aims to answer are:

* Does FF/UMEC/VI improve ventilation defect percent as measured on 129-Xenon MRI in adults with moderate-severe COPD
* Evaluate the relationships between the ventilation defect percent and lung function test results

Participants will:

* Take the inhaler FF/UMEC/VI once daily for 12-weeks (optional 48-weeks)
* visit Robarts 2 times (with optional 3rd visit) for tests and imaging

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg

The investigational drug is a single Ellipta inhaler containing 100 ug fluticasone furoate(inhaled corticosteroid), 62.5 ug umeclidinium(long-acting muscarinic antagonist) and 25 ug vilanterol(long-acting β2-adrenergic agonist). The drug is delivered in an Ellipta inhaler in a single dose once daily.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-09-30
Completion
2027-10-31

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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 NCT07192016 on ClinicalTrials.gov