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 | Not Yet Recruiting Phase 4

• 1 other identifier: ROB0054
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Pulmonary Function; COPD; 129-Xenon; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Measure the effect of FF/UMEC/VI therapy on VDP

  Measured using 129-xenon MRI ventilation defect percent

  12-weeks and optional 48-weeks

• Measure the effect of FF/UMEC/VI on FEV1

  Measured by the forced expiratory volume at 1 second

  at 12-weeks and optional 48-weeks

Secondary Outcomes (12)

• Evaluate the relationship between MRI VDP and lung function

  12-weeks and optional 48-weeks

• Evaluate the relationship between MRI VDP and SGRQ score

  12-weeks and optional 48-weeks

• Evaluate the relationship between MRI VDP and CAT score

  12-weeks and optional 48-weeks

• Evaluate the relationship between MRI VDP and mMRC score

  12-weeks and optional 48-weeks

• Evaluate the relationship between MRI VDP and 6MWD

  12-weeks and optional 48-weeks

Study Arms (1)

Participants with persistent moderate-severe COPD

EXPERIMENTAL

Participants 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.

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

Interventions

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

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.

Also known as: Trelegy

Participants with persistent moderate-severe COPD

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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™

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

Sponsors & Collaborators

• Western University, Canada: lead

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@uwo.ca

Angela Wilson, RRT

CONTACT

519-931-5777; awilson@robarts.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single arm, open-label study

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 25, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share