Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT01937494
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchial Hyperreactivity During Histamine Passive Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D016535', 'term': 'Bronchial Hyperreactivity'}], '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': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'spirometric values in patients exposed passively to histamine during BHR challenge', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'bronchial hyperresponsiveness', 'histamine challenge test', 'spirometry'], 'conditions': ['Asthma', 'Bronchial Hyperresponsiveness']}, 'descriptionModule': {'briefSummary': 'Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction even if they suffer from BHR.The purpose of the study is to determine if patients with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are developing a bronchoconstriction, when placed in the same conditions that the technicians performing these tests.', 'detailedDescription': 'Bronchial hyperresponsiveness (BHR) consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma.BHR is also present in other diseases such as allergic rhinitis, Chronic Obstructive pulmonary disease,heart failure..\n\nThes test is performed with metacholine or histamine with spirometric documented response to incremental doses.Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction if they suffer from BHR.\n\nThe purpose of the study is to determine if patients, newly diagnosed with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are reacting to histamine when placed in the same conditions that the technicians performing these tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with positive histamine challenge test (first dose)\n\nExclusion Criteria:\n\n* other active respiratory disease'}, 'identificationModule': {'nctId': 'NCT01937494', 'briefTitle': 'Bronchial Hyperreactivity During Histamine Passive Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?', 'orgStudyIdInfo': {'id': 'AK/13-03-34/4235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'asthma patients', 'description': 'patients who show a positive response at the first dos of histamine challenge test will be enrolled', 'interventionNames': ['Drug: histamine-benzylic alcohol (magistral preparation)']}], 'interventions': [{'name': 'histamine-benzylic alcohol (magistral preparation)', 'type': 'DRUG', 'description': 'passive exposure to histamine during a bronchial hyperresponsiveness challenge', 'armGroupLabels': ['asthma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'service de pneumologie, CHU St Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marie Bruyneel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU ST Pierre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CCA, pneumologie', 'investigatorFullName': 'Marie Bruyneel', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}