Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT01191359
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2010-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
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': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2010-08-27', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch', 'timeFrame': 'after 4, 8, 12, 24, 36 weeks of treatment', 'description': 'specific antibody determination'}], 'secondaryOutcomes': [{'measure': 'Comparison of the two administration routes with regard to safety aspects', 'timeFrame': '36 weeks', 'description': 'adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of Birch pollen allergy\n* Positive skin prick test to birch\n* Positive specific IgE to birch\n\nExclusion criteria:\n\n* Uncontrolled or severe asthma (FEV1\\<70% of predicted value in spite of adequate pharmacologic treatment)\n* Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years\n* Concomitant SLIT with any allergen'}, 'identificationModule': {'nctId': 'NCT01191359', 'briefTitle': 'Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch', 'orgStudyIdInfo': {'id': 'SP-B-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sublingual administration', 'description': 'oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose)', 'interventionNames': ['Biological: oral immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vestibular administration', 'description': 'oral immunotherapy with drops applied by single dose containers (200 STU per dose)', 'interventionNames': ['Biological: oral immunotherapy']}], 'interventions': [{'name': 'oral immunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['SLITone birch'], 'description': 'orally applied specific immunotherapy', 'armGroupLabels': ['sublingual administration', 'vestibular administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinik Bonn, Dermatology', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Thomas Bieber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäsklinik Bonn, Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}