Trial document





This trial has been registered retrospectively.
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  DRKS00000116

Trial Description

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Title

Cellular and humoral mechanisms of specific immunotherapy (SIT) in respiratory type-I-allergies.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The clinical efficacy of specific immunotherapy (SIT) in the treatment of allergic diseases is well recognised. However, the responsible mechanisms are not sufficiently studied. In this study, blood shall be drawn at different time points from patients with respiratory allergy undergoing SIT to analyse possible changes of different immunological parameters.

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Brief Summary in Scientific Language

The clinical efficiency of specific immunotherapy (SIT) is well recognised, but the immunological mechanisms leading to allergen tolerance are not sufficiently studied. Decisive events are the correction of an imbalance between allergenspecific T lymphocytes of helper-typ 1 and 2 as well as IL-10-producing, type 1 regulatory T cells; In addition, the induction of allergenspecific IgG4-antibodies. In this longitudinal study, the alterations of the frequency and the phenotype of the different T cell subsets, differences in the concentrations of allergenspecifc antibodies and molecular differences shall be characterised in patients with respiratory immediate-type allergy undergoing SIT. Of special interest is the question, if different changes are appearant depending on the method of allergen application and the structure of the allergen.

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Organizational Data

  •   DRKS00000116
  •   2009/04/16
  •   [---]*
  •   yes
  •   Approved
  •   Az 47/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Allergic rhinoconjunctivitis and/or allergic asthma against birch pollen
  •   J30.1 -  Allergic rhinitis due to pollen
  •   J45.0 -  Predominantly allergic asthma
  •   H10.1 -  Acute atopic conjunctivitis
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Interventions/Observational Groups

  •   Study-related taking of blood samples and of nasal discharge for analysis, no further intervention.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Induction of regulatory T cells;
Taking of blood samples before and 1, 3, 6, 12, 18, 24, 30, 36, 42, 48 months after initiation of SIT;
Determination of allergen-specific Treg and Teff frequencies as well as quantification of cytokines and specific antibodies

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2005/10/31
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Rhinoconjunctivitis allergica or allergic asthma with maximal symptoms in the springtime.
Immediate-type sensitisation against birch pollen in clincial tests: positive skin prick test or intracutaneous test against birch pollen.
Positive nasal provocation against birch pollen.
Sensitisation against birch pollen (and the major allergen Bet v 1) detectable in vitro.
Specific IgE at least of CAP-class 2 (against the classical birch pollen allergen) and at least of CAP-class 1 against recombinant Bet v 1.
Signed declaration of consent.

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Exclusion Criteria

Contraindication against specific immunotherapy.
Patients unable to give informed consent.

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Addresses

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    • Klinik für Dermatologie und Allergologie Philipps-Universität Marburg
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Klinik für Dermatologie und Allergologie
    • Mr.  PD Dr. med.  Wolfgang  Pfützner 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Klinik für Dermatologie und Allergologie
    • Mr.  PD Dr. med.  Wolfgang  Pfützner 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • DFG - Deutsche Forschungsgemeinschaft
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Birch pollen immunotherapy leads to differential induction of regulatory T cells and delayed helper T cell immune deviation.

    Möbs C, Slotosch C, Löffler H, Jakob T, Hertl M, Pfützner W.

    J Immunol. 2010;184(4):2194-203
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* This entry means the parameter is not applicable or has not been set.