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

Recruiting now · Phase 4

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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

Key facts

Study ID: NCT07192016
Run by: Western University, Canada
People needed: 60
Starts: 2026-04-24
Expected to finish: 2027-10-01
Last updated by the study team: 2026-07-31

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

patient understands study procedures and is willing to participate in the study as indicated by the patient's signature
provision of written, informed consent prior to any study specific procedures
males and females 50-85 years of age
stable COPD, currently on dual therapy LAMA/LABA or ICS/LABA or initial maintenance therapy for at least 3 months
mMRC score ≥2 and/or CAT score ≥10
Low risk subgroup: participant has experienced ≤1 exacerbation in the past year and no hospitalizations for COPD High risk subgroup: participant has experienced ≥2 exacerbations in the past year
Female of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
True sexual abstinence
A vasectomized sexual partner
Implanon®
Female sterilization by tubal occlusion
Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
Depo-Provera™ injections
Oral contraceptive
Evra Patch™
Nuvaring™
Female permanently sterile due to: 1) documented hysterectomy, 2) documented bilateral salpingectomy, and 3) documented bilateral oophorectomy
Postmenopausal female: defined as female with no menses for 12 months without an alternative medical cause
Females of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and 8 weeks after last dose of study drug, with negative urine pregnancy test taken within 24 hr of any planned CT examination at Visit-1 through Visit 3
Male participants who are sexually active with a woman who can still have children, must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until 8 weeks after last dose

You may not qualify if…

Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist)
In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia
Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit
Participant is unable to perform spirometry or plethysmography maneuvers
Participant is unable to perform MRI and CT breath-hold maneuvers
Participant has an unstable cardiovascular, gastro-intestinal, hepatic, renal, neurologic, metabolic or psychiatric disease
Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study
Known history of allergy or reaction to the study drug formulation
Participant has a blood pressure of >150 mmHg systolic or >95 mmHg diastolic on more than 2 measurements done >5 minutes apart at Visit-1
Participants with a recently (<2 months) documented diagnosis of asthma

Where it is running

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre — London, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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