Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
Study NCT ID:
NCT05138250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-18'}], 'estimatedResultsFirstSubmitDate': '2025-12-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in MRI indices of ventilation, perfusion and inflammation - 52 weeks', 'timeFrame': '52 weeks', 'description': 'Change in MRI indices of ventilation, perfusion and inflammation (see text) - %VV, CV, RBC/TP, TP/gas, RBC/gas, ADC, LmD, Ve, Ktrans, PBV, PBF, MTT, VQ-intersect, T1, M0 at 52 weeks compared to baseline and 12 weeks'}, {'measure': 'Correlation of changes to measures of lung function and inflammation (MRI and physiological)', 'timeFrame': '12 weeks', 'description': 'Correlation of changes in physiological measures and MRI measures of lung function and inflammation (see text) at 12 weeks'}, {'measure': 'Various correlations of change of ventilation, perfusion and inflammation measures', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change in physiological and MRI determined measures of ventilation, perfusion and inflammation at 12 weeks from baseline will be correlated with;\n\n1. Baseline peripheral blood eosinophil count\n2. Baseline FeNO\n3. Change of peripheral blood eosinophil count from baseline to 12 weeks\n4. Change in FeNO from baseline to 12 weeks. Similar correlation will be carried out for data obtained at 52 weeks rather than 12 weeks.'}, {'measure': 'Change in MRI metrics in groups with low or high numbers of moderate to severe exacerbations', 'timeFrame': '12 weeks', 'description': 'Comparison of change in MRI metrics from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total moderate to severe exacerbations over 52 weeks assessed by EXACT-Pro)'}, {'measure': 'Overall impact of mepolizumab treatment on HRQoL in COPD', 'timeFrame': '12 and 52 weeks', 'description': 'Comparison of change of CAT from baseline to 12 and 52 weeks within participants compare to changes in measures of lung function by physiology and MRI.'}, {'measure': 'Overall impact of mepolizumab treatment on HRQoL in COPD', 'timeFrame': '12 and 52 weeks', 'description': 'Comparison of changes in physiological and MRI derived parameters at 12 weeks in groups with either high and low improvement of CAT at 52 weeks (determined by median split)'}, {'measure': 'Correlation of PREFUL and DCE MRI measures', 'timeFrame': '52 weeks (all timepoints)', 'description': 'PREFUL %VV and PREFUL %PV will be correlated with XeMRI and proton MRI determined measures of lung function at all time points'}], 'primaryOutcomes': [{'measure': 'Change in percentage ventilated volume of lung (%VV)', 'timeFrame': '12 weeks', 'description': 'The within subject change in percentage ventilated volume of lung (%VV) assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab'}, {'measure': 'Change in alveolar thickness', 'timeFrame': '12 weeks', 'description': 'The within participant change in TP/gas (a measure of alveolar thickness, as an index of pulmonary inflammation) assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab.'}], 'secondaryOutcomes': [{'measure': 'Change in MRI metrics in low and high exacerbation groups', 'timeFrame': '12 weeks', 'description': 'Comparison of change in MRI metrics from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total exacerbations over 52 weeks assessed by EXACT-Pro)'}, {'measure': 'Change in MRI indices of ventilation, perfusion and inflammation - 12 weeks', 'timeFrame': '12 weeks', 'description': 'Change in MRI indices of ventilation, perfusion and inflammation - CV, RBC/TP, RBC/gas, ADC, LmD, Ve, Ktrans, PBV, PBF, MTT, VQ-intersect, T1, M0 from baseline to 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI, eosinophil, exacerbation'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The investigators aim to recruit 32 people with COPD who have frequent exacerbations and high eosinophil counts which indicates "asthmatic type" inflammation and treat them for a year with mepolizumab. This is a licenced medication for asthma. Mepolizumab is a monoclonal antibody that acts through interleukin-5 (IL-5) antagonism to reduce blood eosinophil levels and is effective at reducing exacerbations in asthmatics. To determine whether mepolizumab may be an effective treatment in people with COPD and "asthmatic type" inflammation participants will have MRI scans before the treatment, after 12 weeks and after a year to see how the drug affects inflammation. The investigators will also compare our measurements with the number of exacerbations people get (measured by diaries), with measures of their quality of life (using a questionnaire), and with ordinary laboratory breathing tests. The investigators are especially interested to know if the reduction in inflammation early on after 12 weeks is associated with fewer exacerbations and better quality of life over the year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD as determined by a post bronchodilator FEV1/FVC \\<70% and an FEV1 of between 20 and 80% at screening visit\n* Treatment with inhaled triple therapy (licensed combination of long acting beta 2 agonist, long acting anti-muscarinic and corticosteroid) at constant dose for at least 12 weeks before screening visit. Treatment with roflumilast, theophyillines and macrolides will be permitted so long as they were introduced at stable dose \\> 12 weeks prior to screening visit. (If maintenance drug dosing has not been with stable dosages for 12 weeks the screening visit may be rescheduled until this is achieved: see sections 7.3 and 7.10)\n* At least 2 acute exacerbations of COPD (AECOPD) requiring treatment with oral steroids and/or antibiotics in the last 12 months, or 1 acute AECOPD requiring hospital admission in the last 12 months.\n* At least one eosinophil count of \\>0.3 cells·μL-1 in the 12 months prior to screening\n* Age over 18 years\n\nExclusion Criteria:\n\n* Contraindication to MRI scanning, including Gadovist (ie hypersensitivity or poor renal function; see below); this includes claustrophobia and musculoskeletal difficulties, this information is collected on the UoS MRI unit screening form.\n* Inability to give informed consent or comply with study procedures\n* Hypersensitivity to mepolizumab or its excipients\n* Untreated helminthic infection\n* Exacerbation of COPD requiring treatment with oral steroids and/or antibiotics within 4 weeks of screening. A repeat screening visit may be scheduled in order to achieve this criterion. The participant will be required to successfully complete all screening procedures at the rescheduled visit, including that for exacerbation-free stability.\n* SpO2 \\<90% on room air at screening\n* Clear history of childhood and/or current asthma\n* Past history of lung surgery\n* Other significant lung disease\n* Long term oral steroid treatment\n* eGFR \\< 30 ml/min/1.73 m2 at screening\n* NYHA class 3 or 4, where the functional limitation from heart disease is greater than that from COPD, or uncompensated heart failure\n* Chronic liver disease (Any elevation of ALT above twice the upper limit of normal at screening. Lower levels of abnormality are permitted after investigator review if felt not to compromise safety)\n* Malignancy unless treated and disease free for 5 years\n* Conditions causing significant immunosuppression\n* Active infection with blood borne viruses (including hepatitis A and B and HIV)\n* Other significant medical condition compromising participant safety or fidelity of study.\n* Pregnant or breast feeding\n* Of childbearing potential and not willing to use highly effective methods of contraception during the course of the study and for 100 days post last dose of mepolizumab.\n* Participants who have received an investigational drug within 30 days of first dose, or within 5 drug half-lives of the investigational drug, whichever is longer'}, 'identificationModule': {'nctId': 'NCT05138250', 'acronym': 'SUMMER', 'briefTitle': 'A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD', 'orgStudyIdInfo': {'id': 'STH21067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm (all participants, not randomised)', 'description': 'All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)', 'interventionNames': ['Drug: Mepolizumab 100 MG']}], 'interventions': [{'name': 'Mepolizumab 100 MG', 'type': 'DRUG', 'description': 'participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks', 'armGroupLabels': ['Treatment arm (all participants, not randomised)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'S Yorkshire', 'country': 'United Kingdom', 'facility': 'Clinical Research Facility - NGH', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Rod Lawson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sheffield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}