Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

Study Overview
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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.

Official Title
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Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.

Conditions
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Mite Allergy, Allergic Asthma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mite allergic patients without SIT<br>patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy | |
| mite allergic patients with SIT<br>patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in BAP | significant improvement of PD20FEV1-mite in BAP | one year after initiation of SIT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life and medication | Via questionnaire (adapted from ISAAC-study) we assessed the quality of life, clinical symptoms and medication scores of the patients included | 1 year after initiation of SIT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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specific immunotherapy, bronchial allergen provocation, specific IgE, specific IgG, specific IgG4, SIT