Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06026202
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Eosinophilic Biological Effects of IL-5
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood mononuclear cells Bronchial epithelial cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.', 'timeFrame': '1 year', 'description': 'Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR(copies/ml) of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin 5', 'Bronchial epithelial cells', 'Peripheral blood mononuclear cells', 'Peripheral dendritic cells', 'Interferon', 'Rhinovirus'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5 people with asthma.', 'detailedDescription': 'IL-5 has been shown to be present in higher levels in those with asthma, more so during viral infection. The investigators know from existing evidence that having increased levels of interferon (IFN) reduces asthma exacerbations and viral load. The investigators suspect that IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs) and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN. The aim is to investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of IFNs. The investigators also will evaluate if anti-IL-5 therapies suppress IL-5 concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against asthma exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those with mild asthma on as required salbutamol only.', 'healthyVolunteers': False, 'eligibilityCriteria': "Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma' (MAELABA) (19SM5101)."}, 'identificationModule': {'nctId': 'NCT06026202', 'briefTitle': 'Non-Eosinophilic Biological Effects of IL-5', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Non-Eosinophilic Biological Effects of Interleukin 5 (IL-5) - Role of IL-5 in Suppressing Anti-Viral Immunity in Bronchial Epithelial Cells and Dendritic Cells in Asthma', 'orgStudyIdInfo': {'id': '326910'}}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sebastian L Johnston, MBBS', 'role': 'CONTACT', 'email': 's.johnston@imperial.ac.uk', 'phone': '+442075943764'}, {'name': 'Eva Fiorenzo, BMBS', 'role': 'CONTACT', 'email': 'efiorenz@ic.ac.uk', 'phone': '+442075943751'}], 'facility': 'Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Sebastian L Johnston, MBBS', 'role': 'CONTACT', 'email': 's.johnston@imperial.ac.uk', 'phone': '+44 20 7594 3764'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}