Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-05 @ 7:21 AM
Study NCT ID:
NCT03898466
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fluticasone Furoate on Methacholine Challenge
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methacholine provocation dose causing a 20% fall in FEV1 (PD20)', 'timeFrame': '24 hours post dose, 72 hours post dose and 168 hours post dose', 'description': 'Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo'}], 'secondaryOutcomes': [{'measure': 'Fractional exhaled nitric oxide (FeNO)', 'timeFrame': '168 hours', 'description': 'Change from baseline on levels of fractional exhaled nitric oxide'}, {'measure': 'Sputum eosinophils', 'timeFrame': 'Baseline', 'description': 'Assessment of induced sputum differential cell counts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '31434037', 'type': 'DERIVED', 'citation': 'Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted\n* methacholine PD20 less than or equal to 400mcg\n* no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start\n\nExclusion Criteria:\n\n* regular use of inhaled corticosteroid within 4 weeks of study start\n* poorly controlled asthma\n* current smoker or ex smoker with greater than 10 pack year history\n* pregnancy or breast-feeding\n* health concern/condition that would preclude participation for safety reasons'}, 'identificationModule': {'nctId': 'NCT03898466', 'briefTitle': 'Effect of Fluticasone Furoate on Methacholine Challenge', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics', 'orgStudyIdInfo': {'id': 'Bio ID 366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluticasone Furoate', 'description': 'Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.\n\nThe change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints', 'interventionNames': ['Drug: Fluticasone furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.\n\nThe change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints', 'interventionNames': ['Other: Matching placebo']}], 'interventions': [{'name': 'Fluticasone furoate', 'type': 'DRUG', 'otherNames': ['Arnuity'], 'description': 'Inhaled corticosteroid', 'armGroupLabels': ['Fluticasone Furoate']}, {'name': 'Matching placebo', 'type': 'OTHER', 'description': 'Placebo inhaler', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Don Cockcroft', 'investigatorAffiliation': 'University of Saskatchewan'}}}}