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
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada
RECRUITINGMeasure 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
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