Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-30 @ 3:13 PM
Study NCT ID:
NCT03097094
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Allergy: Separate Allergies to Male and Female Dogs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Male vs. female dog SPT in Can f 5 mono sensitized patients', 'timeFrame': '6 months', 'description': 'In the patients that have a positive SPT (\\> 2mm) to dog and are monosensitized to the Can f 5 component, the investigatiors want to compare the reaction to SPT (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures.'}], 'secondaryOutcomes': [{'measure': 'Male vs. female dog conjunctival provocation in Can f 5 mono sensitized patients', 'timeFrame': '6 months', 'description': 'In the patients that have a positive SPT (\\> 2mm) to dog and are monosensitized to the Can f 5 component, the investigatiors want to compare the reaction to conjunctival provocation (positive/negative) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures.'}, {'measure': 'Male vs. female dog SPT in dog poly sensitized patients', 'timeFrame': '6 months', 'description': 'In the patients that have a positive SPT (\\> 2mm) to dog and are sensitized to the Can f 1, 2 and/or 3 component, the investigatiors want to compare the reaction to SPT (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures.'}, {'measure': 'Male vs. female dog conjunctival provocation in dog poly sensitized patients', 'timeFrame': '6 months', 'description': 'In the patients that have a positive SPT (\\> 2mm) to dog and are sensitized to the Can f 1, 2 and/or 3 component, the investigatiors want to compare the reaction to conjunctival provocation (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures.'}, {'measure': 'Can f 5 vs. SPT size', 'timeFrame': '6 months', 'description': 'To investigate the correlation between specific Immunoglobulin E (sIgE) level to the Can f 5 component and the SPT wheal size to the male dog extract using a general linear model.'}, {'measure': 'Can f 5 vs. conjunctival provocation', 'timeFrame': '6 months', 'description': 'To investigate the correlation between sIgE level to the Can f 5 component and the threshold of reaction to the male dog extract at the conjunctival provocation, using a general linear model.'}, {'measure': 'SPT vs. conjunctival provocation', 'timeFrame': '6 months', 'description': 'To investigate the correlation between SPT wheal size to the male dog extract and the threshold of reaction to the male dog extract at the conjunctival provocation, using a general linear model.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dog allergy', 'Can f 5', 'Male dog', 'Female dog', 'Allergen components'], 'conditions': ['Allergy; Dander']}, 'descriptionModule': {'briefSummary': 'A new male-specific dog-allergen-component has been found (Can f 5) which indicates possible differences in allergic reactions to male and female dogs. This has not yet been tested in real life.\n\nThe aim is to test if sensitization only to the male-dog specific allergen-component, Can f 5, results in a positive skin prick test (SPT) to male dog extract and not female dog extract. In addition, the investigators want to investigate if allergic symptoms only occur when exposed to the male dog extract by conjunctival provocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in the COPSAC 2000 cohort\n* Positive component test (\\>0.3 ISU) to Can f 1, Can f 2, Can f 3 or Can f 5\n\nExclusion Criteria:\n\n* Uncontrolled asthma\n* Eye-surgery within the past 6 months\n* Antihistamine allergy\n* and others'}, 'identificationModule': {'nctId': 'NCT03097094', 'briefTitle': 'Precision Allergy: Separate Allergies to Male and Female Dogs', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen Studies on Asthma in Childhood'}, 'officialTitle': 'Precision Allergy: Separate Allergies to Male and Female Dogs', 'orgStudyIdInfo': {'id': 'Dog allergy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Male dog', 'description': 'Male dog extract used for skin prick test and conjunctival provocation', 'interventionNames': ['Diagnostic Test: Male dog']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Female dog', 'description': 'Female dog extract used for skin prick test and conjunctival provocation', 'interventionNames': ['Diagnostic Test: Female dog']}], 'interventions': [{'name': 'Male dog', 'type': 'DIAGNOSTIC_TEST', 'description': 'Male dog extract', 'armGroupLabels': ['Male dog']}, {'name': 'Female dog', 'type': 'DIAGNOSTIC_TEST', 'description': 'Female dog extract', 'armGroupLabels': ['Female dog']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copsac, Dbac', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Klaus Bønnelykke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen Studies on Asthma in Childhood'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen Studies on Asthma in Childhood', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}