A Phase 4 interventional study of fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Western University, Canada · Phase 4, Interventional, and Treatment
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:
Participants will:
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).
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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
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
Measure the effect of FF/UMEC/VI therapy on VDP
Measured using 129-xenon MRI ventilation defect percent
Time frame: 12-weeks and optional 48-weeks
Measure the effect of FF/UMEC/VI on FEV1
Measured by the forced expiratory volume at 1 second
Time frame: at 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and lung function
measured using MRI ventilation defect percent and forced expiratory volume at 1 second
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and SGRQ score
measured using 129-xenon MRI ventilation defect percent and St. George's Respiratory Questionnaire score
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and CAT score
Measured using 129-xenon MRI ventilation defect percent and COPD Assessment Test score
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and mMRC score
Measured using 129-xenon MRI ventilation defect percent and modified Medical Research Council questionnaire score
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and 6MWD
Measured using 129-xenon MRI ventilation defect percent and six-minute walk distance.
Time frame: 12-weeks and optional 48-weeks
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.
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and blood inflammatory markers
Measured using 129-xenon MRI ventilation defect percent and blood eosinophil count
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and CT measurements
Measured using 129-xenon MRI ventilation defect percent and CT mucus-score
Time frame: 12-weeks and optional 48-weeks
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
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and lung volume
Measured using MRI ventilation defect percent and forced vital capacity
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and CT measurements
Measured using MRI ventilation defect percent and CT mucus-count
Time frame: 12-weeks and optional 48-weeks
Evaluate the relationship between MRI VDP and CT measurements
Measured using MRI ventilation defect percent and CT mucus-volume
Time frame: 12-weeks and optional 48-weeks
Plan to share: No
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Pulmonary Disease, Chronic Obstructive→
Western University, Canada