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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-85
SponsorWestern University, Canada

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators