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

November 22, 2011
November 23, 2011
July 2010
November 2010   (final data collection date for primary outcome measure)
improvement in BAP [ Time Frame: one year after initiation of SIT ] [ Designated as safety issue: No ]
significant improvement of PD20FEV1-mite in BAP
Same as current
Complete list of historical versions of study NCT01479205 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

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

  • Mite Allergy
  • Allergic Asthma
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01479205
FRAITASIT
No
Stefan Zielen, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Stefan Zielen, Prof. Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP