Clinical Trials Directory

Trials / Completed

CompletedNCT01479205

Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

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

Status
Completed
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Johann Wolfgang Goethe University Hospital · Academic / Other
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2010-07-01
Primary completion
2010-11-01
Completion
2011-09-01
First posted
2011-11-24
Last updated
2011-11-24

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01479205. Inclusion in this directory is not an endorsement.