Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT01699594
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in Airway Responsiveness After Allergen Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008353', 'term': 'Mannitol'}, {'id': 'D016210', 'term': 'Methacholine Chloride'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008688', 'term': 'Methacholine Compounds'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in airway responsiveness three hours after allergen exposure', 'timeFrame': 'Change from Baseline at 3 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'allergies', 'mannitol', 'methacholine'], 'conditions': ['Allergic Asthma']}, 'referencesModule': {'references': [{'pmid': '23987192', 'type': 'DERIVED', 'citation': 'Amakye DO, Davis BE, Martin AL, Peters GE, Cockcroft DW. Refractoriness to inhaled mannitol 3 hours after allergen challenge. Ann Allergy Asthma Immunol. 2013 Sep;111(3):182-4. doi: 10.1016/j.anai.2013.06.011. Epub 2013 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild, allergic asthma\n* FEV1 greater than 70% predicted\n* methacholine PC20 less than or equal to 16mg/ml\n\nExclusion Criteria:\n\n* known sensitivity to mannitol or other excipient\n* diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating\n* recent thoracic, abdominal or eye surgery\n* recent allergen exposure (4 weeks), respiratory infection (6 weeks)\n* current immunotherapy\n* pregnancy\n* history of anaphylaxis\n* use of asthma therapies other than short acting beta agonist'}, 'identificationModule': {'nctId': 'NCT01699594', 'briefTitle': 'Change in Airway Responsiveness After Allergen Exposure', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity', 'orgStudyIdInfo': {'id': 'IIS-A-524'}, 'secondaryIdInfos': [{'id': 'BioReb #10-227', 'type': 'OTHER', 'domain': 'University of Saskatchewan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mannitol', 'description': 'This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.', 'interventionNames': ['Drug: Mannitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methacholine Chloride', 'description': 'This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.', 'interventionNames': ['Drug: Methacholine Chloride']}], 'interventions': [{'name': 'Mannitol', 'type': 'DRUG', 'otherNames': ['Aridol'], 'description': 'Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)', 'armGroupLabels': ['Mannitol']}, {'name': 'Methacholine Chloride', 'type': 'DRUG', 'otherNames': ['Provocholine'], 'description': 'Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)', 'armGroupLabels': ['Methacholine Chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Donald W Cockcroft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}