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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Zielen, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01479205
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Mite Allergy
Allergic Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • improvement in BAP [ Time Frame: one year after initiation of SIT ] [ Designated as safety issue: No ]
    significant improvement of PD20FEV1-mite in BAP


Secondary Outcome Measures:
  • Improvement of quality of life and medication [ Time Frame: 1 year after initiation of SIT ] [ Designated as safety issue: No ]
    Via questionnaire (adapted from ISAAC-study) we assessed the quality of life, clinical symptoms and medication scores of the patients included


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 42
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
mite allergic patients without SIT
patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy
mite allergic patients with SIT
patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged 6-17 years of age with house dust mite allergy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479205

Locations
Germany
Department of Paediatric Allergy and Pulmonology
Frankfurt (Main), Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, Prof. Johann Wolfgang Goethe University Hospitals
  More Information

Publications:

Responsible Party: Stefan Zielen, Prof. Dr. med Stefan Zieln, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01479205     History of Changes
Other Study ID Numbers: FRAITASIT
Study First Received: November 22, 2011
Last Updated: November 23, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
specific immunotherapy
bronchial allergen provocation
specific IgE
 specific IgG
specific IgG4
SIT

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013