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Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

NCT ID: NCT01479205

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mite Allergy Allergic Asthma

Keywords

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specific immunotherapy bronchial allergen provocation specific IgE specific IgG specific IgG4 SIT

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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mite allergic patients without SIT

patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy

No interventions assigned to this group

mite allergic patients with SIT

patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* informed consent
* between 5 and 18 years of age
* diagnosis of a moderate Asthma bronchiale (I-II) in the last 12 months or rhino conjunctivitis
* no exacerbation \> 4 weeks before Visit

Exclusion Criteria

* age \< 5 years \> 18 years,
* FEV1 \< 75%
* no cooperation to undergo the BAP,
* exacerbation within the last 28 days before Visit
* other serious illnesses
* taking part in other clinical trials \< 30 days
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefan Zielen

Prof. Dr. med Stefan Zieln

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Zielen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital

Locations

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Department of Paediatric Allergy and Pulmonology

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20687065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20645937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20883456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21912178 (View on PubMed)

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.

Reference Type RESULT
PMID: 20001651 (View on PubMed)

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.

Reference Type RESULT
PMID: 18849616 (View on PubMed)

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.

Reference Type RESULT
PMID: 20345983 (View on PubMed)

Other Identifiers

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FRAITASIT

Identifier Type: -

Identifier Source: org_study_id