COPD (Chronic Obstructive Pulmonary Disease)Phase 4ADORENCT07749001

Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab

A Phase 4 study testing Mepolizumab 100 MG Injection in people with COPD (Chronic Obstructive Pulmonary Disease), run by Western University, Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: COPD (Chronic Obstructive Pulmonary Disease)
What is being tested?: Mepolizumab 100 MG Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: 1 Oct 2026to 1 Apr 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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.
Women of non-childbearing potential will be included.
Such females will be:
Permanently sterile due to one of the following procedures:
Documented hysterectomy.
Documented bilateral salpingectomy.
Documented bilateral oophorectomy. For permanently sterile individuals due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), investigator discretion should be applied to determining study entry. If reproductive status is questionable, additional evaluation should be considered.
Note: Documentation will stem from review of participant's medical records, medical examination, or medical history interview.
Postmenopausal female. Females who are confirmed post-menopausal for ≥ 1year. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in participants not using hormonal contraception or HRT. In the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.
Females on HRT and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.

Who cannot join

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.

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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.
Participants with a current malignancy or previous history of cancer in remission for less than 12 months prior to Baseline Visit 1 (localized carcinoma of the skin or cervix resected for cure not excluded).
Participants with a known immunodeficiency (e.g., human immunodeficiency virus-HIV).
Participants with cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. NOTE: stable non-cirrhotic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (in whom Hepatitis D (HDV) has been excluded)) or C are acceptable if participant otherwise meets entry criteria.
Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Previous exposure to monoclonal antibodies targeting IL-5/5R, IL-4R/IL-13, IL-33, or TSLP within 6 months or 5 half-lives, prior to Baseline Visit 1.
Previous documented failure with anti-IL-5/5R or anti-IL-4R/IL-13 therapy.
Other monoclonal antibodies: participants who have received any monoclonal antibody within 5 half-lives of Screening Visit 1.
Participants who have received short term use of oral corticosteroids within 4 weeks of Visit 1.
Previous randomization in the present study.
Concurrent enrolment in another clinical trial.
12-lead ECG at Baseline Visit 1: participants with QT interval corrected with Fridericia's formula (QTcF) > 450 ms (or QTcF > 480 ms in participants with bundle branch block).
QTcF is the QT interval corrected for heart rate according to Fridericia's formula that is selected for this study. It is either machine-read or manually over-read when not automatically machine read. This specific formula must be used to determine eligibility for an individual participant.
Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Baseline Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
Where a single ECG demonstrates a prolonged QTcF interval, obtain two more ECGs readings at a minimum of 2 minutes apart over a brief recording period (e.g., 5-10 minutes), The average of the triplicate QTcF measurements should be used to determine eligibility.
Participants with a known allergy or sensitivity to any of the study interventions or study treatment, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.
Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Participants with conditions that will limit the validity of informed consent to participate in the study, e.g., uncontrolled psychiatric disease or intellectual deficiency.
A known or suspected history of alcohol or drug abuse within 2 years prior to Baseline Visit 1.
For sputum induction, participants who have had previous bronchospasm or prior intolerance to a hypertonic saline solution, poorly controlled COPD on the day of sample collection, or oxygen saturation of less than 88% on room air will not take part in the induced sputum collection.
Female participants: Women of childbearing potential (after menarche) will NOT be enrolled.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Grace E Parraga, PhD contact

519-931-5265

gparraga@uwo.ca

Angela Wilson, RRT contact

519-931-5111 ext. 24197

awilson@robarts.ca

About this study

Official title: Airway Dysfunction, Occlusions and RemodEling: COPD Patients and Mepolizumab (ADORE)

Does mepolizumab improve ventilation defect percent as measured on 129-Xenon MRI in adults with COPD.
Does mepolizumab improve the amount of mucus plugs in the lungs as measured by lung CT in adults with COPD.

Participants will:

Take mepolizumab by subcutaneous injection every 4 weeks for the duration of the study.
Visit Robarts 4 times over 48 weeks for tests and imaging.

Read the detailed description

This is a 48 week, single-arm study to evaluate the effect of mepolizumab on lung structure and functions evaluated using pulmonary MRI and CT imaging in 36 patients with COPD. Study treatment will be administered at a baseline visit and every 4 weeks, with clinic visits at baseline, week-12, week-24, and week-48.

After providing written, informed consent, all study visits participants will have vital signs recorded and undergo pre- and post-bronchodilator spirometry, plethysmography, oscillometry, pre-bronchodilator forced exhaled nitric oxide (FeNO) and post-bronchodilator diffusing capacity of the lungs for carbon monoxide (DLco). Participants will undergo pre- and post-bronchodilator 129-Xe MRI and post-bronchodilator chest computed tomography (CT) (CT at Visits 1, 3, 4). Participants will complete St. George's Respiratory Questionnaire (SGRQ), Modified Medical Research Council (mMRC), COPD Assessment Test (CAT), Borg rating of perceived exertion questionnaire will be completed before and after the six-minute walk test (6MWT). Participants will have a blood draw for complete blood count (CBC). Participants will undergo sputum induction at Visits 1 and 4.

Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Being tested: Mepolizumab 100 MG Injection
Keywords: 129-Xenon, Pulmonary Function, Magnetic Resonance Imaging, COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mepolizumab 100 MG InjectionDrug
Also called Nucala
mepolizumab 100mg will be administered subcutaneously once every 4 weeks starting at baseline visit-1 through to visit 4 (48 weeks).

Study groups in NCT07749001
Study group	Role	What they receive
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. Receives: Drug: Mepolizumab 100 MG Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab (100 mg) on CT airway mucus-count.
Measured using CT airway mucus-count.
Measured: 24-weeks and 48-weeks.

Secondary outcomes (28)

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.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab (100 mg) using CT airway mucus-count in all participants.
Measured using CT mucus-count in all participants.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on FEV1.
Measured using Forced Exhaled Volume at 1 Second (FEV1).
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure in all participants.
Measured using change from baseline in CT mucus-score.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on pulmonary vascular structure in all participants.
Measured using change from baseline in pulmonary vascular small vessel volume (BV5).
Measured: 24-weeks and 48-weeks.
To evaluate the relationships between MRI VDP and lung function.
Measured using 129-MRI ventilation defect percent and forced expiratory volume at 1 second.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationships for MRI VDP with SGRQ.
Measured using 129-xenon MRI ventilation defect percent and St. George's Respiratory Questionnaire score.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and mMRC.
Measured using 129-xenon MRI ventilation defect percent and the Modified Medical Research Council dyspnea scale questionnaire score.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship for MRI VDP with CAT score.
Measured using 129-xenon MRI ventilation defect percent and COPD Assessment Test questionnaire score.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship for MRI VDP with 6MWD.
Measured using 129-xenon MRI ventilation defect percent with six-minute walk distance.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and blood inflammatory markers.
Measured using 129-xenon MRI ventilation defect percent and blood eosinophil count.
Measured: 12-weeks, 24-weeks, 48-weeks
To evaluate the relationship between MRI VDP and CT markers of type 2 inflammation.
Measured by 129-xenon MRI ventilation defect percent and CT mucus-score.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate baseline VDP as a predictor of exacerbations.
Measured using 129-xenon MRI ventilation defect percent and the number of exacerbations during the treatment period as reported by the participant.
Measured: 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Change from baseline in CT mucus volume.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure.
Change from baseline in CT mucus density.
Measured: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Change from baseline in CT mucus texture.
Measured: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Change from baseline in CT airway wall thickness.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure.
Change from baseline in CT airway lumen area.
Measured: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT airway structure.
Change from baseline in CT total airway count.
Measured: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on pulmonary vascular structure.
Measured using change from baseline in CT pulmonary vascular large vessel volume (BV10).
Measured: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT pulmonary vascular structure.
Measured using change from baseline in CT pulmonary vascular total blood volume (TBV).
Measured: 24-weeks and 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Measured using 129-xenon MRI ventilation defect percent and forced vital capacity.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Measured using 129-xenon MRI ventilation defect percent and the ratio of forced exhaled volume at 1 second to forced vital capacity.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung volumes.
Measured using 129-xenon MRI ventilation defect percent and functional residual capacity.
Measured: 12-weeks, 24-weeks, 48-weeks
To evaluate the relationship between MRI VDP and lung volumes.
Measured using 129-xenon MRI ventilation defect percent and total lung capacity.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Measured using 1299-xenon MRI ventilation defect percent and diffusing capacity for carbon monoxide value.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and CT markers of inflammation.
Measured using 129-xenon MRI ventilation defect percent and CT mucus-count.
Measured: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and CT markers of inflammation.
Measured using 129-xenon MRI ventilation defect percent and CT mucus-volume.
Measured: 12-weeks, 24-weeks, 48-weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20261 Apr 2028

First posted6 Aug 2026
Study start1 Oct 2026 (estimated)
Primary completion28 Feb 2028 (estimated)
Study completion1 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
More trials run by Western University, CanadaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm, open label study
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07749001
Sponsor's protocol ID: ROB0062
Acronym: ADORE
Status last verified: Jul 2026
First submitted: 27 Jul 2026
Last updated: 6 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mozaffaripour A, Tcherner S, Durom E, Kooner HK, McIntosh MJ, Sherwood M, Paul N, Serajeddini H, Bhalla A, Yamashita C, Parraga G. Airway mucus and 129Xe MRI ventilation after single inhaler triple therapy in asthma. ERJ Open Res. 2025 Oct 13;11(5):01333-2024. doi: 10.1183/23120541.01333-2024. eCollection 2025 Sep.
PubMed 41089567
Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective multiple test procedures. Stat Med. 2009 Feb 15;28(4):586-604. doi: 10.1002/sim.3495.
PubMed 19051220
McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.
PubMed 678885
Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
PubMed 1595997
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809
Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
PubMed 8756799
Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.
PubMed 38127464
Svenningsen S, Haider E, Boylan C, Mukherjee M, Eddy RL, Capaldi DPI, Parraga G, Nair P. CT and Functional MRI to Evaluate Airway Mucus in Severe Asthma. Chest. 2019 Jun;155(6):1178-1189. doi: 10.1016/j.chest.2019.02.403. Epub 2019 Mar 23.
PubMed 30910637
Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.
PubMed 29400693
Gevenois PA, De Vuyst P, de Maertelaer V, Zanen J, Jacobovitz D, Cosio MG, Yernault JC. Comparison of computed density and microscopic morphometry in pulmonary emphysema. Am J Respir Crit Care Med. 1996 Jul;154(1):187-92. doi: 10.1164/ajrccm.154.1.8680679.
PubMed 8680679
Estepar RS, Ross JC, Krissian K, Schultz T, Washko GR, Kindlmann GL. COMPUTATIONAL VASCULAR MORPHOMETRY FOR THE ASSESSMENT OF PULMONARY VASCULAR DISEASE BASED ON SCALE-SPACE PARTICLES. Proc IEEE Int Symp Biomed Imaging. 2012:1479-1482. doi: 10.1109/ISBI.2012.6235851.
PubMed 23743962
Costella S, Kirby M, Maksym GN, McCormack DG, Paterson NA, Parraga G. Regional pulmonary response to a methacholine challenge using hyperpolarized (3)He magnetic resonance imaging. Respirology. 2012 Nov;17(8):1237-46. doi: 10.1111/j.1440-1843.2012.02250.x.
PubMed 22889229
Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
PubMed 22104288
Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PubMed 31613151

Interested in taking part?

Grace E Parraga, PhD

519-931-5265

gparraga@uwo.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Airway Dysfunction, Occlusions and RemodEling: COPD Patients and Mepolizumab (ADORE)
ClinicalTrials.gov ID: NCT07749001
Acronym / sponsor ID: ADORE / ROB0062
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: 129-Xenon, Pulmonary Function, Magnetic Resonance Imaging, COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: Western University, CanadaUniversity, hospital or other
Study start: 1 Oct 2026 (estimated)
Primary completion: 28 Feb 2028 (estimated)
Study completion: 1 Apr 2028 (estimated)
First posted: 6 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Does mepolizumab improve ventilation defect percent as measured on 129-Xenon MRI in adults with COPD.
Does mepolizumab improve the amount of mucus plugs in the lungs as measured by lung CT in adults with COPD.

Participants will:

Take mepolizumab by subcutaneous injection every 4 weeks for the duration of the study.
Visit Robarts 4 times over 48 weeks for tests and imaging.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm, open label study

Arm	Type	Receives
Participants with persistent COPD on triple therapy	Experimental	Drug: Mepolizumab 100 MG InjectionParticipants 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.

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

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.

Key exclusion criteria (35 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mepolizumab 100 MG InjectionAlso: Nucalamepolizumab 100mg will be administered subcutaneously once every 4 weeks starting at baseline visit-1 through to visit 4 (48 weeks).	Drug	Participants with persistent COPD on triple therapy

Primary outcome

To measure the effect of mepolizumab (100mg) on MRI ventilation defect percent in participants with no severe exacerbations during the study period.
Time frame: 24-weeks and 48-weeks.
Measured using 129-Xenon ventilation defect percent.
To measure the effect of mepolizumab (100 mg) on CT airway mucus-count.
Time frame: 24-weeks and 48-weeks.
Measured using CT airway mucus-count.

28 secondary outcomes

To measure the effect of mepolizumab (100mg) using MRI ventilation defect percent in all participants.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab (100 mg) using CT airway mucus-count in all participants.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on FEV1.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure in all participants.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on pulmonary vascular structure in all participants.
Time frame: 24-weeks and 48-weeks.
To evaluate the relationships between MRI VDP and lung function.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationships for MRI VDP with SGRQ.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and mMRC.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship for MRI VDP with CAT score.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship for MRI VDP with 6MWD.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and blood inflammatory markers.
Time frame: 12-weeks, 24-weeks, 48-weeks
To evaluate the relationship between MRI VDP and CT markers of type 2 inflammation.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate baseline VDP as a predictor of exacerbations.
Time frame: 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure.
Time frame: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Time frame: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT markers of airway structure.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on CT markers of airway structure.
Time frame: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT airway structure.
Time frame: 24-weeks and 48-weeks.
To measure the effect of mepolizumab on pulmonary vascular structure.
Time frame: 24-weeks and 48-weeks
To measure the effect of mepolizumab on CT pulmonary vascular structure.
Time frame: 24-weeks and 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung volumes.
Time frame: 12-weeks, 24-weeks, 48-weeks
To evaluate the relationship between MRI VDP and lung volumes.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and lung function.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and CT markers of inflammation.
Time frame: 12-weeks, 24-weeks, 48-weeks.
To evaluate the relationship between MRI VDP and CT markers of inflammation.
Time frame: 12-weeks, 24-weeks, 48-weeks.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Background: PubMed 41089567Mozaffaripour A, Tcherner S, Durom E, Kooner HK, McIntosh MJ, Sherwood M, Paul N, Serajeddini H, Bhalla A, Yamashita C, Parraga G. Airway mucus and 129Xe MRI ventilation after single inhaler triple therapy in asthma. ERJ Open Res. 2025 Oct 13;11(5):01333-2024. doi: 10.1183/23120541.01333-2024. eCollection 2025 Sep.
Background: PubMed 19051220Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective multiple test procedures. Stat Med. 2009 Feb 15;28(4):586-604. doi: 10.1002/sim.3495.
Background: PubMed 678885McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.
Background: PubMed 1595997Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
Background: PubMed 8756799Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
Background: PubMed 38127464Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.
Background: PubMed 30910637Svenningsen S, Haider E, Boylan C, Mukherjee M, Eddy RL, Capaldi DPI, Parraga G, Nair P. CT and Functional MRI to Evaluate Airway Mucus in Severe Asthma. Chest. 2019 Jun;155(6):1178-1189. doi: 10.1016/j.chest.2019.02.403. Epub 2019 Mar 23.
Background: PubMed 29400693Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.
Background: PubMed 8680679Gevenois PA, De Vuyst P, de Maertelaer V, Zanen J, Jacobovitz D, Cosio MG, Yernault JC. Comparison of computed density and microscopic morphometry in pulmonary emphysema. Am J Respir Crit Care Med. 1996 Jul;154(1):187-92. doi: 10.1164/ajrccm.154.1.8680679.
Background: PubMed 23743962Estepar RS, Ross JC, Krissian K, Schultz T, Washko GR, Kindlmann GL. COMPUTATIONAL VASCULAR MORPHOMETRY FOR THE ASSESSMENT OF PULMONARY VASCULAR DISEASE BASED ON SCALE-SPACE PARTICLES. Proc IEEE Int Symp Biomed Imaging. 2012:1479-1482. doi: 10.1109/ISBI.2012.6235851.
Background: PubMed 22889229Costella S, Kirby M, Maksym GN, McCormack DG, Paterson NA, Parraga G. Regional pulmonary response to a methacholine challenge using hyperpolarized (3)He magnetic resonance imaging. Respirology. 2012 Nov;17(8):1237-46. doi: 10.1111/j.1440-1843.2012.02250.x.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Grace E Parraga, PhD contact

519-931-5265

gparraga@uwo.ca

Angela Wilson, RRT contact

519-931-5111 ext. 24197

awilson@robarts.ca

Grace Parraga, PhD principal investigator

Robarts Research Institute, The University of Western Ontario

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mepolizumab 100 MG Injection in people with COPD (Chronic Obstructive Pulmonary Disease), run by Western University, Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace E Parraga, PhD (519-931-5265, gparraga@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure the effect of mepolizumab (100mg) on MRI ventilation defect percent in participants with no severe exacerbations during the study period. (time frame: 24-weeks and 48-weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07749001, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.