Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-20 @ 9:02 AM
Study NCT ID:
NCT03739320
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011657', 'term': 'Pulmonary Eosinophilia'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in daily moving time', 'timeFrame': '7 days', 'description': 'Moving time in minutes'}, {'measure': 'Change in daily movement intensity', 'timeFrame': '7 days', 'description': 'Movement intensity in m/s\\^2'}, {'measure': 'Change in daily time in moderate-to-vigorous-intensity activity', 'timeFrame': '7 days', 'description': 'Time in moderate-to-vigorous-intensity activity in minutes'}, {'measure': 'Change in daily steps', 'timeFrame': '7 days', 'description': 'Step count'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe asthma', 'biologic therapy', 'physical activity monitoring'], 'conditions': ['Severe Eosinophilic Asthma']}, 'descriptionModule': {'briefSummary': "Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.", 'detailedDescription': 'A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with severe asthma, already on maximal and optimised treatment who fulfil the criteria for mepolizumab add-on therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe asthma\n2. Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.\n\nExclusion Criteria: Comorbidities limiting physical activity'}, 'identificationModule': {'nctId': 'NCT03739320', 'briefTitle': 'A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Sotiria General Hospital'}, 'officialTitle': 'A Prospective Observational Study on the Effect of Mepolizumab add-on Therapy on Daily Physical Activity in Patients With Severe Eosinophilic Asthma', 'orgStudyIdInfo': {'id': '451'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mepolizumab 100 MG Injection [Nucala]', 'type': 'DRUG', 'description': '100 milligrams subcutaneously once every 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Marios Panagiotou, MD', 'role': 'CONTACT', 'email': 'mpanagiotou@med.uoa.gr', 'phone': '+00306974238267'}], 'facility': 'Sotiria General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Marios Panagiotou, MD', 'role': 'CONTACT', 'email': 'mpanagiotou@med.uoa.gr', 'phone': '+306974238267'}, {'name': 'Nikoletta Rovina, MD', 'role': 'CONTACT', 'email': 'nikrovina@med.uoa.gr', 'phone': '+306945830212\u202c'}], 'overallOfficials': [{'name': 'Marios Panagiotou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sotiria General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sotiria General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Respiratory Physician, PhD student', 'investigatorFullName': 'Marios Panagiotou', 'investigatorAffiliation': 'Sotiria General Hospital'}}}}