Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

Completed

• Conditions: Allergic Asthma; Mite Allergy

• Registration Number: NCT01479205
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-11
• Study Completion: 2011-09
• Status Verified: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Study First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in BAP	one year after initiation of SIT	significant improvement of PD20FEV1-mite in BAP

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Paediatric Allergy and Pulmonology; 🇩🇪 Frankfurt (Main), Germany