Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55-85
SponsorWestern University, Canada
About this trial
The goal of this study is to evaluate the effect of mepolizumab on patients with COPD using MRI and CT imaging as well as breathing tests. The study will evaluate the response to this medication after 24 and 48 weeks of treatment. The main questions it aims to answer are:
1. Does mepolizumab improve ventilation defect percent as measured on 129-Xenon MRI in adults with COPD. 2. Does mepolizumab improve the amount of mucus plugs in the lungs as measured by lung CT in adults with COPD.
Participants will:
1. Take mepolizumab by subcutaneous injection every 4 weeks for the duration of the study. 2. Visit Robarts 4 times over 48 weeks 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 55-85 years of age.
An eosinophilic phenotype with elevated BEC with a documented measurement of ≥ 300 cells/µL at Baseline/screening Visit 1.
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.
Participant is unable to perform spirometry or plethysmography maneuvers.
Participant is unable to perform MRI and CT breath-hold maneuvers.
Trial design
Treatments tested in this trial
- Mepolizumab 100 MG Injection
Treatment groups
36 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov