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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Mepolizumab 100 MG Injection
Drugmepolizumab 100mg will be administered subcutaneously once every 4 weeks starting at baseline visit-1 through to visit 4 (48 weeks).
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Participants with persistent COPD on triple therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To measure the effect of mepolizumab (100mg) on MRI ventilation defect percent in participants with no severe exacerbations during the study period.
Measured using 129-Xenon ventilation defect percent.
Time frame
24-weeks and 48-weeks.2
To measure the effect of mepolizumab (100 mg) on CT airway mucus-count.
Measured using CT airway mucus-count.
Time frame
24-weeks and 48-weeks.Secondary outcomes
1
To measure the effect of mepolizumab (100mg) using MRI ventilation defect percent in all participants.
Measured using 129-Xenon ventilation defect percent in all participants.
Time frame
24-weeks and 48-weeks.2
To measure the effect of mepolizumab (100 mg) using CT airway mucus-count in all participants.
Measured using CT mucus-count in all participants.
Time frame
24-weeks and 48-weeks.3
To measure the effect of mepolizumab on FEV1.
Measured using Forced Exhaled Volume at 1 Second (FEV1).
Time frame
24-weeks and 48-weeks.4
To measure the effect of mepolizumab on CT markers of airway structure in all participants.
Measured using change from baseline in CT mucus-score.
Time frame
24-weeks and 48-weeks.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: