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
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
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
Single group
fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg
DrugThe 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.
Measure the effect of FF/UMEC/VI therapy on VDP
Measured using 129-xenon MRI ventilation defect percent
Measure the effect of FF/UMEC/VI on FEV1
Measured by the forced expiratory volume at 1 second
Evaluate the relationship between MRI VDP and lung function
measured using MRI ventilation defect percent and forced expiratory volume at 1 second
Evaluate the relationship between MRI VDP and SGRQ score
measured using 129-xenon MRI ventilation defect percent and St. George's Respiratory Questionnaire score
Evaluate the relationship between MRI VDP and CAT score
Measured using 129-xenon MRI ventilation defect percent and COPD Assessment Test score
Evaluate the relationship between MRI VDP and mMRC score
Measured using 129-xenon MRI ventilation defect percent and modified Medical Research Council questionnaire score
Click on the lead sponsor to view all of their trials.
