Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-29 @ 8:43 AM
Study NCT ID:
NCT01964768
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010328', 'term': 'Patch Tests'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-14', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The secondary measurement was also the specific IgE level for each allergen.', 'timeFrame': 'Specific IgE results were known after the study visit, an expected average of 3 days.'}], 'primaryOutcomes': [{'measure': 'Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.', 'timeFrame': 'For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.'}], 'secondaryOutcomes': [{'measure': 'One of the secondary measurement was the wheal diameter for each allergen.', 'timeFrame': 'SPT measurements were performed after the study visit, an expected average of 1 week.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:\n\n* 5 Grasses pollen,\n* Birch pollen,\n* Dermatophagoides pteronyssinus mite'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent to participate in the study\n* Male or female subjects aged 5-60 years inclusive\n* Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test\n* Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)\n* Subjects affiliated to a social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Dermographism\n* Absence of cutaneous reactivity\n* Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test\n* Subjects presenting unstable asthma or poor general health condition\n* Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years\n* Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine\n* Subjects on anti-IgE treatment\n* Subjects treated with beta-blockers and/or anti-depressives.\n* Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial\n* Investigators, co-investigators, as well as their children or spouses and all the study collaborators\n* Subjects under protection of the courts, legal guardianship or legal trusteeship'}, 'identificationModule': {'nctId': 'NCT01964768', 'briefTitle': 'Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing', 'orgStudyIdInfo': {'id': 'DG40.08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Skin prick-test', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frédéric de Blay, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}