Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT04750603
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}, {'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Medications and placebos were provided by the hospital pharmacy and medications were given by the nurse. Randomization was generated by computer, independently of trial staff as described (Salbutamol inhaler + Ellipta placebo or FF/VI + placebo Salbutamol inhaler). Technicians performing the ECT, investigators and patients were blinded to treatment choice'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First phase: Randomized, double blind, double dummy. Second phase: open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term effect of FF/VI', 'timeFrame': '30-60 days', 'description': 'Exercise challenge test following FF/VI treatment'}], 'secondaryOutcomes': [{'measure': 'Short term effect of FF/VI', 'timeFrame': '15 minutes', 'description': 'Effect of FF/VI on post exercise change in pulmonary function test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': 'Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.', 'detailedDescription': 'Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent asthmatics aged 12-18 years\n* Symptoms of shortness of breath on exercise and asthmatics before entry to military service\n* Referral for evaluation of exercise challenge test\n\nExclusion Criteria:\n\n* Baseline FEV1\\<65% before exercise test\n* Acute illness\n* History of intolerance to beta agonists\n* Use of the following medications prior to the study was restricted: inhaled corticosteroids or Montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)'}, 'identificationModule': {'nctId': 'NCT04750603', 'acronym': 'EIA', 'briefTitle': 'Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial', 'orgStudyIdInfo': {'id': 'RMB-107-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Salbutamol', 'description': 'Salbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo', 'interventionNames': ['Drug: Salbutamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FF/VI', 'description': 'Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK)', 'interventionNames': ['Drug: Fluticasone furoate (FF)/Vilanterol (VI)']}], 'interventions': [{'name': 'Fluticasone furoate (FF)/Vilanterol (VI)', 'type': 'DRUG', 'otherNames': ['Relvar®'], 'description': 'Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints', 'armGroupLabels': ['FF/VI']}, {'name': 'Salbutamol', 'type': 'DRUG', 'otherNames': ['Salbutrim'], 'description': 'Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints.', 'armGroupLabels': ['Salbutamol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Lea Bentur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD is not planned to be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Lea Bentur', 'investigatorFullName': 'l_bentur', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}