Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02327234
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway response to inhaled allergen', 'timeFrame': 'at time of allergen inhalation challenge and for 7 hours after', 'description': 'area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)'}], 'secondaryOutcomes': [{'measure': 'Airway response to inhaled methacholine', 'timeFrame': 'day before allergen inhalation challenge and 8 hours after allergen inhalation challenge', 'description': 'delta log methacholine PC20 (provocative concentration of methacholine causing a 20% decrease in the forced expiratory volume in one second)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Asthma']}, 'referencesModule': {'references': [{'pmid': '27222654', 'type': 'DERIVED', 'citation': 'Nomani S, Cockcroft DW, Davis BE. Allergen inhalation challenge, refractoriness and the effects of ibuprofen. Allergy Asthma Clin Immunol. 2016 May 24;12:24. doi: 10.1186/s13223-016-0127-z. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently\n* has allergies that trigger asthma\n* responds to methacholine challenge at 16mg/ml or less\n* has FEV1 \\> 69.5% predicted\n\nExclusion Criteria:\n\n* respiratory illness within 4 weeks\n* other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data\n* pregnant or lactating females\n* hypersensitivity to ibuprofen'}, 'identificationModule': {'nctId': 'NCT02327234', 'briefTitle': 'Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process', 'orgStudyIdInfo': {'id': 'Bio REB 14-283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'description': '400mg (2X200mg) ibuprofen single dose once', 'interventionNames': ['Drug: ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'identical appearing lactose capsules single dose 2 capsules once', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ibuprofen', 'type': 'DRUG', 'otherNames': ['Advil'], 'description': '2x 200mg ibuprofen, single dose, blinded in 00 capsules', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'lactose filled 00 capsules to match appearance of ibuprofen intervention', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Don Cockcroft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'journal publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Don Cockcroft', 'investigatorAffiliation': 'University of Saskatchewan'}}}}