Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT01479205
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-23', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in BAP', 'timeFrame': 'one year after initiation of SIT', 'description': 'significant improvement of PD20FEV1-mite in BAP'}], 'secondaryOutcomes': [{'measure': 'Improvement of quality of life and medication', 'timeFrame': '1 year after initiation of SIT', 'description': 'Via questionnaire (adapted from ISAAC-study) we assessed the quality of life, clinical symptoms and medication scores of the patients included'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['specific immunotherapy', 'bronchial allergen provocation', 'specific IgE', 'specific IgG', 'specific IgG4', 'SIT'], 'conditions': ['Mite Allergy', 'Allergic Asthma']}, 'referencesModule': {'references': [{'pmid': '20687065', 'type': 'BACKGROUND', 'citation': 'Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD001186. doi: 10.1002/14651858.CD001186.pub2.'}, {'pmid': '20645937', 'type': 'BACKGROUND', 'citation': 'Pfaar O, Robinson DS, Sager A, Emuzyte R. Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis. Allergy. 2010 Dec;65(12):1614-21. doi: 10.1111/j.1398-9995.2010.02413.x.'}, {'pmid': '20883456', 'type': 'BACKGROUND', 'citation': 'Blumberga G, Groes L, Dahl R. SQ-standardized house dust mite immunotherapy as an immunomodulatory treatment in patients with asthma. Allergy. 2011 Feb;66(2):178-85. doi: 10.1111/j.1398-9995.2010.02451.x. Epub 2010 Sep 30.'}, {'pmid': '21912178', 'type': 'BACKGROUND', 'citation': 'Schulze J, Rosewich M, Dressler M, Riemer C, Rose MA, Zielen S. Bronchial allergen challenge using the Medicaid dosimeter. Int Arch Allergy Immunol. 2012;157(1):89-97. doi: 10.1159/000324473. Epub 2011 Sep 7.'}, {'pmid': '20001651', 'type': 'RESULT', 'citation': 'Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.'}, {'pmid': '18849616', 'type': 'RESULT', 'citation': 'Schubert R, Eickmeier O, Garn H, Baer PC, Mueller T, Schulze J, Rose MA, Rosewich M, Renz H, Zielen S. Safety and immunogenicity of a cluster specific immunotherapy in children with bronchial asthma and mite allergy. Int Arch Allergy Immunol. 2009;148(3):251-60. doi: 10.1159/000161585. Epub 2008 Oct 10.'}, {'pmid': '20345983', 'type': 'RESULT', 'citation': 'Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'One aim of this study was to find out if the bronchial allergen provocation (BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The investigators had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively the investigators analysed the data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November 2008 till February 2010). Prospectively The investigators analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. The investigators mean parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT.', 'detailedDescription': 'One aim of this study was to find out if the bronchial allergen provocation(BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). We had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively we analysed the data of the first BAP (PD20FEV1, VC, FEV1, FEV1/VC (%), eNO) and allergic blood parameters like specific IgE-mite, total IgE, cumulative IgE before SIT (November 2008 till February 2010). Prospectively we analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. Our mean parameter was PD20FEV1-mite. Another aim of our study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, we compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT. Additionally all patients answered a questionnaire according to ISAAC about their clinical symptoms, their quality of life and their medication score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 6-17 years of age with house dust mite allergy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* between 5 and 18 years of age\n* diagnosis of a moderate Asthma bronchiale (I-II) in the last 12 months or rhino conjunctivitis\n* no exacerbation \\> 4 weeks before Visit\n\nExclusion Criteria:\n\n* age \\< 5 years \\> 18 years,\n* FEV1 \\< 75%\n* no cooperation to undergo the BAP,\n* exacerbation within the last 28 days before Visit\n* other serious illnesses\n* taking part in other clinical trials \\< 30 days'}, 'identificationModule': {'nctId': 'NCT01479205', 'acronym': 'ITASIT', 'briefTitle': 'Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.', 'orgStudyIdInfo': {'id': 'FRAITASIT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mite allergic patients without SIT', 'description': 'patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy'}, {'label': 'mite allergic patients with SIT', 'description': 'patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Department of Paediatric Allergy and Pulmonology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stefan Zielen, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med Stefan Zieln', 'investigatorFullName': 'Stefan Zielen', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}