Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab

NCT07749001 | Not Yet Recruiting Phase 4

• 1 other identifier: ROB0062
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Does mepolizumab improve ventilation defect percent as measured on 129-Xenon MRI in adults with COPD.
2. 2.Does mepolizumab improve the amount of mucus plugs in the lungs as measured by lung CT in adults with COPD.
3. 3.Take mepolizumab by subcutaneous injection every 4 weeks for the duration of the study.
4. 4.Visit Robarts 4 times over 48 weeks for tests and imaging.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

129-Xenon; Pulmonary Function; Magnetic Resonance Imaging; COPD

Outcome Measures

Primary Outcomes (2)

• 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.

  24-weeks and 48-weeks.

• To measure the effect of mepolizumab (100 mg) on CT airway mucus-count.

  Measured using CT airway mucus-count.

  24-weeks and 48-weeks.

Secondary Outcomes (28)

• To measure the effect of mepolizumab (100mg) using MRI ventilation defect percent in all participants.

  24-weeks and 48-weeks.

• To measure the effect of mepolizumab (100 mg) using CT airway mucus-count in all participants.

  24-weeks and 48-weeks.

• To measure the effect of mepolizumab on FEV1.

  24-weeks and 48-weeks.

• To measure the effect of mepolizumab on CT markers of airway structure in all participants.

  24-weeks and 48-weeks.

• To measure the effect of mepolizumab on pulmonary vascular structure in all participants.

  24-weeks and 48-weeks.

Study Arms (1)

Participants with persistent COPD on triple therapy

EXPERIMENTAL

Participants with moderate to severe COPD will be evaluated during and after a forty-eight week trial of mepolizumab for changes in 129Xe MRI ventilation percent defect, CT mucus-counts. Mepolizumab 100mg is administered subcutaneously once every four weeks for the duration of the study.

Drug: Mepolizumab 100 MG Injection

Interventions

Mepolizumab 100 MG Injection DRUG

mepolizumab 100mg will be administered subcutaneously once every 4 weeks starting at baseline visit-1 through to visit 4 (48 weeks).

Also known as: Nucala

Participants with persistent COPD on triple therapy

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• CT mucus-count ≥ 3 on baseline/screening CT OR on previous clinical CT acquired within last 12 weeks AND evaluable for mucus occlusions.
• Moderate to severe COPD with frequent exacerbations, defined as:
• A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year.
• A post-salbutamol FEV1/FVC ratio of \< 0.70 and a post-salbutamol FEV1 ≥ 30% and \< 80% predicted at screening.
• A well-documented history (e.g., medical record verification) of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening:
• At least one qualifying exacerbation must have occurred while participant is on ICS-LAMA-LABA.
• Moderate exacerbations must have been treated with systemic corticosteroids.
• Severe exacerbations are those requiring hospitalization (i.e., ≥ 24 hours)
• Smoking status: Ex-cigarette smokers (quit ≥ 1 year) with a history of cigarette smoking of ≥ 10 pack-years at Baseline/screening Visit 1.
• Participants should be on maintenance inhaler therapy, defined as ICS+LAMA+LABA, either as multiple inhalers or a single combination inhaler for at least 3 months prior to Baseline Visit 1.
• Participants on adjunctive COPD therapies such as roflumilast, chronic macrolide antibiotics may participate, provided they have been on these medications for at least 6 months, and on a stable dose for at least 3 months immediately prior to Baseline Visit 1. These participants should remain on these therapies for the duration of the study.

You may not qualify if:

• 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.
• Participants with any diagnosis of asthma at any time are excluded. A diagnosis of asthma should be based on both a history of typical respiratory symptoms combined with evidence of variable expiratory airflow limitation at the time of diagnosis consistent with GINA 2023 or other accepted guidelines.
• Participants with α1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
• Participants with pneumonia, active COPD exacerbation at screening/baseline visit, or lower respiratory tract infection within the 4 weeks prior to Baseline Visit 1.
• Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure.
• Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Baseline Visit 1 are excluded. Participants who are in the maintenance phase of a pulmonary rehabilitation program may participate.
• Patients requiring oxygen supplementation for more than 12 hours per day are excluded. Non-continuous (i.e., 12 hours or less per day) oxygen is permitted up to 2 L/min at screening.
• Participants with Cor-pulmonale resulting in right heart failure, severe pulmonary hypertension.
• Participants with chronic hypercapnia requiring BiPAP.
• Participants with unstable cardiovascular disease.
• Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA, also known as Churg-Strauss Syndrome), or Eosinophilic Esophagitis.
• Participants with a known, pre-existing parasitic infection within 6 months of Baseline Visit 1.

Sponsors & Collaborators

• Western University, Canada: lead

Related Publications (31)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

mepolizumab; Injections

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Grace Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@uwo.ca

Angela Wilson, RRT

CONTACT

519-931-5111; awilson@robarts.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm, open label study

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share