Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT00540150
Status:
COMPLETED
Last Update Posted:
2007-10-05
First Post:
2007-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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': 'C014135', 'term': 'Novo-Helisen Depot'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-04', 'studyFirstSubmitDate': '2007-10-02', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the shortened specific immunotherapy.', 'timeFrame': 'may 2004 - march 2005'}], 'secondaryOutcomes': [{'measure': 'Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.', 'timeFrame': 'may 2004 - march 2005'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Mite', 'Asthma', 'bronchial provocation', 'SIT', 'specific immunotherapy'], 'conditions': ['Immunotherapy']}, 'referencesModule': {'references': [{'pmid': '12915987', 'type': 'BACKGROUND', 'citation': 'Hansen I, Hormann K, Stuck BA, Schneider-Gene S, Mosges R, Klimek L. [Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)]. Laryngorhinootologie. 2003 Aug;82(8):558-63. doi: 10.1055/s-2003-41234. German.'}, {'pmid': '15990782', 'type': 'BACKGROUND', 'citation': 'Tabar AI, Echechipia S, Garcia BE, Olaguibel JM, Lizaso MT, Gomez B, Aldunate MT, Martin S, Marcotegui F. Double-blind comparative study of cluster and conventional immunotherapy schedules with Dermatophagoides pteronyssinus. J Allergy Clin Immunol. 2005 Jul;116(1):109-18. doi: 10.1016/j.jaci.2005.05.005.'}]}, 'descriptionModule': {'briefSummary': 'We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.\n\nTherefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent of patient and/or parents\n* age \\>6 and \\<18 years\n* bronchial asthma I° or II°\n* allergy on house dust-mite\n\nExclusion Criteria:\n\n* age \\<6 and \\>18 years\n* vital capacity \\<80% or FEV1 \\<70%\n* pregnancy\n* inhalative or systemic steroid use\n* bronchial asthma III° or IV°\n* heavy exacerbation during the last 3 months'}, 'identificationModule': {'nctId': 'NCT00540150', 'briefTitle': 'Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.', 'orgStudyIdInfo': {'id': '97/04/FFM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany', 'interventionNames': ['Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany', 'interventionNames': ['Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)']}], 'interventions': [{'name': 'specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)', 'type': 'BIOLOGICAL', 'otherNames': ['Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany'], 'description': 'We treat each patient with mite-allergen following the two different protocols.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University, Department of Pulmonology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stefan Zielen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University, Department of Pulmonology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergopharma GmbH & Co. KG', 'class': 'INDUSTRY'}]}}}