Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

NCT01479205 | Completed

• 1 other identifier: FRAITASIT
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mite Allergy; Allergic Asthma

Keywords

specific immunotherapy; bronchial allergen provocation; specific IgE; specific IgG; specific IgG4; SIT

Outcome Measures

Primary Outcomes (1)

• improvement in BAP

  significant improvement of PD20FEV1-mite in BAP

  one year after initiation of SIT

Secondary Outcomes (1)

• Improvement of quality of life and medication

  1 year after initiation of SIT

Study Arms (2)

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

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Department of Paediatric Allergy and Pulmonology

Frankfurt am Main, 60590, Germany

Location

Related Publications (7)

• Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD001186. doi: 10.1002/14651858.CD001186.pub2.

  PMID: 20687065 BACKGROUND

• Pfaar O, Robinson DS, Sager A, Emuzyte R. Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis. Allergy. 2010 Dec;65(12):1614-21. doi: 10.1111/j.1398-9995.2010.02413.x.

  PMID: 20645937 BACKGROUND

• Blumberga G, Groes L, Dahl R. SQ-standardized house dust mite immunotherapy as an immunomodulatory treatment in patients with asthma. Allergy. 2011 Feb;66(2):178-85. doi: 10.1111/j.1398-9995.2010.02451.x. Epub 2010 Sep 30.

  PMID: 20883456 BACKGROUND

• Schulze J, Rosewich M, Dressler M, Riemer C, Rose MA, Zielen S. Bronchial allergen challenge using the Medicaid dosimeter. Int Arch Allergy Immunol. 2012;157(1):89-97. doi: 10.1159/000324473. Epub 2011 Sep 7.

  PMID: 21912178 BACKGROUND

• Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.

  PMID: 20001651 RESULT

• Schubert R, Eickmeier O, Garn H, Baer PC, Mueller T, Schulze J, Rose MA, Rosewich M, Renz H, Zielen S. Safety and immunogenicity of a cluster specific immunotherapy in children with bronchial asthma and mite allergy. Int Arch Allergy Immunol. 2009;148(3):251-60. doi: 10.1159/000161585. Epub 2008 Oct 10.

  PMID: 18849616 RESULT

• Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.

  PMID: 20345983 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Stefan Zielen, Prof.

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med Stefan Zieln

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: September 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

DE (1)