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Completed

NCT Number: NCT01479205

Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatric Allergy and Pulmonology

Frankfurt am Main, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. improvement in BAP

    Time frame: one year after initiation of SIT

    significant improvement of PD20FEV1-mite in BAP

Secondary outcomes

  1. Improvement of quality of life and medication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Acronym: ITASIT

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 24, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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