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Chronic Obstructive Pulmonary Disease (COPD)Phase 4MUSTNCT07192016

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

A Phase 4 study testing fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Western University, Canada at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
24 Apr 2026to Oct 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grace E Parraga, PhD contact

519-931-5265

gparraga@uwo.ca

Angela Wilson, RRT contact

519-931-5777 ext. 24197

awilson@robarts.ca

Canada1 site, 1 recruiting

  • Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

    London, Ontario, N6A 5B7

    Grace Parraga, PhD, 519-931-5265, gparraga@uwo.ca

    Angela Wilson, 519-931-5777 ext. 24197, awilson@robarts.ca

    Recruiting

Other trials in Canada

About this study

Official title: Mechanistic 129-Xe MRI Study of Single Inhaler FF/UMEC/VI Effects in COPD Patients With Persistent, Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation

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
Read more

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
Read the detailed description

This study will evaluate 60 COPD patients age 50-85 (equal numbers males and females) with persistent, moderate-severe dyspnea, poor health status and either: 1) low risk of exacerbation (n=30) or moderate-high risk of exacerbation (n=30). Two visits at baseline and 12-weeks are proposed with an optional visit at 48-weeks to assess longitudinal effects of therapy.

At all study visits participants will have vital signs recorded and undergo pre- and post-bronchodilator spirometry, plethysmography, oscillometry, pre-bronchodilator forced exhaled nitric oxide (FeNO) and post-bronchodilator diffusing capacity of the lungs for carbon monoxide (DLco). Participants will undergo pre- and post-bronchodilator 129-Xe MRI and post-bronchodilator chest computed tomography (CT). Participants will complete St. George's Respiratory Questionnaire (SGRQ), Modified Medical Research Council (mMRC), COPD Assessment Test (CAT), Borg rating of perceived exertion questionnaire will be completed before and after the six-minute walk test (6MWT). Participants will have a blood draw for complete blood count (CBC).

Being tested
fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg
Keywords
Pulmonary Function, COPD, 129-Xenon, Magnetic Resonance Imaging
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Trelegy

    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.

Study groups in NCT07192016
Study groupRoleWhat they receive
Participants with persistent moderate-severe COPDExperimentalParticipants with moderate to severe COPD will be evaluated during and after a twelve week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
Receives: Drug: fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure the effect of FF/UMEC/VI therapy on VDP

    Measured using 129-xenon MRI ventilation defect percent

    Measured: 12-weeks and optional 48-weeks

  2. Measure the effect of FF/UMEC/VI on FEV1

    Measured by the forced expiratory volume at 1 second

    Measured: at 12-weeks and optional 48-weeks

Secondary outcomes (12)

  1. Evaluate the relationship between MRI VDP and lung function

    measured using MRI ventilation defect percent and forced expiratory volume at 1 second

    Measured: 12-weeks and optional 48-weeks

  2. Evaluate the relationship between MRI VDP and SGRQ score

    measured using 129-xenon MRI ventilation defect percent and St. George's Respiratory Questionnaire score

    Measured: 12-weeks and optional 48-weeks

  3. Evaluate the relationship between MRI VDP and CAT score

    Measured using 129-xenon MRI ventilation defect percent and COPD Assessment Test score

    Measured: 12-weeks and optional 48-weeks

  4. Evaluate the relationship between MRI VDP and mMRC score

    Measured using 129-xenon MRI ventilation defect percent and modified Medical Research Council questionnaire score

    Measured: 12-weeks and optional 48-weeks

  5. Evaluate the relationship between MRI VDP and 6MWD

    Measured using 129-xenon MRI ventilation defect percent and six-minute walk distance.

    Measured: 12-weeks and optional 48-weeks

  6. Evaluate and compare potential differences in MRI VDP response among patients with low- and high-risk of exacerbation.

    Measured using 129-xenon MRI ventilation defect percent and comparing exacerbation rates across patients with low- and high-risk of exacerbation.

    Measured: 12-weeks and optional 48-weeks

  7. Evaluate the relationship between MRI VDP and blood inflammatory markers

    Measured using 129-xenon MRI ventilation defect percent and blood eosinophil count

    Measured: 12-weeks and optional 48-weeks

  8. Evaluate the relationship between MRI VDP and CT measurements

    Measured using 129-xenon MRI ventilation defect percent and CT mucus-score

    Measured: 12-weeks and optional 48-weeks

  9. Evaluate change in VDP as a predictor of annualized exacerbation rate

    Measured using change in 129-xenon MRI ventilation defect percent with annualized exacerbation rate as reported by the participant

    Measured: 12-weeks and optional 48-weeks

  10. Evaluate the relationship between MRI VDP and lung volume

    Measured using MRI ventilation defect percent and forced vital capacity

    Measured: 12-weeks and optional 48-weeks

  11. Evaluate the relationship between MRI VDP and CT measurements

    Measured using MRI ventilation defect percent and CT mucus-count

    Measured: 12-weeks and optional 48-weeks

  12. Evaluate the relationship between MRI VDP and CT measurements

    Measured using MRI ventilation defect percent and CT mucus-volume

    Measured: 12-weeks and optional 48-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start24 Apr 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single arm, open-label study
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192016
Sponsor's protocol ID
ROB0054
Acronym
MUST
Status last verified
Jul 2026
First submitted
10 Sep 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.

    PubMed 678885

  • Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.

    PubMed 1595997

  • Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

    PubMed 19720809

  • Kaushik SS, Robertson SH, Freeman MS, He M, Kelly KT, Roos JE, Rackley CR, Foster WM, McAdams HP, Driehuys B. Single-breath clinical imaging of hyperpolarized (129)Xe in the airspaces, barrier, and red blood cells using an interleaved 3D radial 1-point Dixon acquisition. Magn Reson Med. 2016 Apr;75(4):1434-43. doi: 10.1002/mrm.25675. Epub 2015 May 18.

    PubMed 25980630

  • Costella S, Kirby M, Maksym GN, McCormack DG, Paterson NA, Parraga G. Regional pulmonary response to a methacholine challenge using hyperpolarized (3)He magnetic resonance imaging. Respirology. 2012 Nov;17(8):1237-46. doi: 10.1111/j.1440-1843.2012.02250.x.

    PubMed 22889229

  • Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.

    PubMed 22104288

  • King GG, Bates J, Berger KI, Calverley P, de Melo PL, Dellaca RL, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, Kaminsky DA, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oppenheimer BW, Simpson SJ, Thamrin C, van den Berge M, Oostveen E. Technical standards for respiratory oscillometry. Eur Respir J. 2020 Feb 27;55(2):1900753. doi: 10.1183/13993003.00753-2019. Print 2020 Feb.

    PubMed 31772002

  • Bhakta NR, McGowan A, Ramsey KA, Borg B, Kivastik J, Knight SL, Sylvester K, Burgos F, Swenson ER, McCarthy K, Cooper BG, Garcia-Rio F, Skloot G, McCormack M, Mottram C, Irvin CG, Steenbruggen I, Coates AL, Kaminsky DA. European Respiratory Society/American Thoracic Society technical statement: standardisation of the measurement of lung volumes, 2023 update. Eur Respir J. 2023 Oct 12;62(4):2201519. doi: 10.1183/13993003.01519-2022. Print 2023 Oct.

    PubMed 37500112

  • Graham BL, Brusasco V, Burgos F, Cooper BG, Jensen R, Kendrick A, MacIntyre NR, Thompson BR, Wanger J. 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung. Eur Respir J. 2017 Jan 3;49(1):1600016. doi: 10.1183/13993003.00016-2016. Print 2017 Jan.

    PubMed 28049168

  • Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

    PubMed 31613151

  • Schmidt MH, Marshall J, Downie J, Hadskis MR. Pediatric magnetic resonance research and the minimal-risk standard. IRB. 2011 Sep-Oct;33(5):1-6. No abstract available.

    PubMed 22043743

  • Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15.

    PubMed 22591724

  • Driehuys B, Martinez-Jimenez S, Cleveland ZI, Metz GM, Beaver DM, Nouls JC, Kaushik SS, Firszt R, Willis C, Kelly KT, Wolber J, Kraft M, McAdams HP. Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Radiology. 2012 Jan;262(1):279-89. doi: 10.1148/radiol.11102172. Epub 2011 Nov 4.

    PubMed 22056683

  • Kirby M, Pike D, Sin DD, Coxson HO, McCormack DG, Parraga G. COPD: Do Imaging Measurements of Emphysema and Airway Disease Explain Symptoms and Exercise Capacity? Radiology. 2015 Dec;277(3):872-80. doi: 10.1148/radiol.2015150037. Epub 2015 Jul 7.

    PubMed 26151081

  • Kirby M, Eddy RL, Pike D, Svenningsen S, Coxson HO, Sin DD, McCormack DG, Parraga G; Canadian Respiratory Research Network. MRI ventilation abnormalities predict quality-of-life and lung function changes in mild-to-moderate COPD: longitudinal TINCan study. Thorax. 2017 May;72(5):475-477. doi: 10.1136/thoraxjnl-2016-209770. Epub 2017 Mar 3.

    PubMed 28258250

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace E Parraga, PhD (519-931-5265, gparraga@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the effect of FF/UMEC/VI therapy on VDP (time frame: 12-weeks and optional 48-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192016, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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