ITASITSecurity of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.
Data Collection
Collected from today forward - ProspectiveCase-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: July 1, 2010
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Paediatric Allergy and Pulmonology
Frankfurt am Main, GermanyOpen Department of Paediatric Allergy and Pulmonology in Google Maps