Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy (ITASIT)

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Mite Allergy; Allergic Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT01479205

FRAITASIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

mite allergic patients without SIT

Description:

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

mite allergic patients with SIT

Description:

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