Actively Recruiting
Study of Once-Daily Single Inhaler Triple Therapy FFUMECVI Effects Using 129-Xe MRI in Adults 50-85 With Moderate to Severe COPD and Different Risks of Flare-Ups
Led by Western University, Canada · Updated on 2026-07-31
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a 12-week daily inhaler therapy combining fluticasone furoate, umeclidinium, and vilanterol affects adults aged 50 to 85 with moderate to severe COPD. The study includes equal numbers of males and females with persistent symptoms and compares those at low and high risk of COPD flare-ups. It aims to understand if this triple therapy improves lung ventilation as measured by 129-Xenon MRI and how this relates to lung function tests. Participants will use a single Ellipta inhaler containing the three medications once daily for 12 weeks, with an optional additional 48 weeks of treatment. They will attend two main visits at baseline and after 12 weeks, with an optional third visit at 48 weeks to assess longer-term effects. The study observes participants responses during and after therapy. During visits, participants undergo various lung function tests including spirometry, plethysmography, oscillometry, and exhaled nitric oxide measurement. They will have 129-Xe MRI scans and chest CT scans before and after bronchodilator use. Questionnaires assessing respiratory symptoms, health status, and exertion are completed, along with a blood draw for inflammatory markers. Researchers measure ventilation defect percentage and lung function changes to evaluate therapy effects over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient understands study procedures and is willing to participate
- Provides written informed consent before study procedures
- Male or female aged 50 to 85 years
- Stable COPD, on dual therapy LAMA/LABA or ICS/LABA or initial maintenance therapy for at least 3 months
- Breathlessness score (mMRC) of 2 or higher and/or COPD Assessment Test (CAT) score of 10 or higher
- Low risk group: 1 or fewer exacerbations in past year and no hospitalizations for COPD
- High risk group: 2 or more exacerbations in past year
- Females of childbearing potential must use effective birth control from 2 months before imaging visits and throughout study
- Females permanently sterile or postmenopausal as defined
- Negative pregnancy test before CT scans for females of childbearing potential
- Males sexually active with women who can have children must use double barrier contraception from first dose until 8 weeks after last dose
You will not qualify if you...
- Implanted devices or metal in body that cannot be removed, including pacemakers and neurostimulators
- Physical or psychological conditions preventing MRI or CT, such as severe claustrophobia
- Pregnant, breastfeeding, or positive pregnancy test at screening
- Unable to perform spirometry or plethysmography maneuvers
- Unable to perform MRI and CT breath-hold maneuvers
- Unstable cardiovascular, gastrointestinal, hepatic, renal, neurologic, metabolic, or psychiatric disease
- Participation in another investigational trial within 3 months before screening or during study
- Known allergy or reaction to study drug
- Blood pressure above 150/95 mmHg on more than 2 measurements at baseline
- Recent asthma diagnosis within past 2 months
Research Team
G
Grace E Parraga, PhD
A
Angela Wilson, RRT
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