Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004635

Trial Description

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Title

SFB/TR22 - Allergic immune reaction in the lung

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Trial Acronym

SFB A22: CLARA study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to better understand the development of allergic diseases, primarily asthma, in childhood. This may offer new options for preventive and therapeutic strategies. We are interested in differences in regulation of the immune system when asthma development has its onset. In this study we include children at the age of 4-14 years. After detailed clinical examination and diagnostics they are defined in 3 groups (allergic asthmatics, non-allergic asthmatics and healthy controls).

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Brief Summary in Scientific Language

Allergic asthma in childhood is described as a dysregulation of the immune system in favor of a pro-allergic Th2 phenotype. The Th2/Th1-imbalance may be mediated by dysregulation of regulatory T cells and potentially also by interaction with pro-inflammatory Th17 cells. Both the allergic and non-allergic asthma phenotype are clinically relevant. The focus of this project is the investigation of regulatory T- and Th17 cells in interaction with Th1/Th2-cells in children with allergic and non-allergic asthma.

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Organizational Data

  •   DRKS00004635
  •   2014/04/23
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  •   yes
  •   Approved
  •   379-08, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   J45.9 -  Asthma, unspecified
  •   J45.0 -  Predominantly allergic asthma
  •   J45.8 -  Mixed asthma
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Interventions/Observational Groups

  •   Allergic asthmatics

    (clinical examination, lung funciton, measurement of exhaled nitric oxide, blood withdrawal, throat swab)
  •   Non-allergic asthmatics
    (clinical examination, lung funciton, measurement of exhaled nitric oxide, blood withdrawal, throat swab)
  •   Healthy controls
    (clinical examination, blood withdrawal, throat swab)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Characterization of T cell marker

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Secondary Outcome

Characterization of immune regulation in peripheral blood mononuclear cells.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/02/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   14   Years
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Additional Inclusion Criteria

Inclusion criteria:
Age 4-14, recurrent pulmonary infections with airway obstruction / wheeze, more than 3 doctor´s diagnosed obstructive bronchitis. Intake of short-or long- acting beta 2-agonists, inhaled corticosteroides, leukotriene antagonists. Detailed clinical examination including lung-function.

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Exclusion Criteria

Exclusion criteria for asthmatics:
Any other pulmonary diseases (e.g. cystic fibrosis, bronchopulmonary dysplasia), any other chronic diseas, autoimmune diseases, immune deficiency, fever 14 day before inclusion, intake of antibiotics and probiotics 14 day before inclusion, intake of corticosteroides 14 days before inclusion, hypersensitization-therapy

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Exclusion criteria for healthy controls:
Any pulmonary diseases (e.g. cystic fibrosis, bronchopulmonary dysplasia), any allergic diseases, any other chronic diseas, autoimmune diseases, immune deficiency, fever 14 day before inclusion, intake of antibiotics or probiotics 14 day before inclusion

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. von Haunersches Kinderspital
    • Ms.  PD Dr. med.  Bianca  Schaub 
    • Lindwurmstraße 4
    • 80337  München
    • Germany
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    • Dr. von Haunersches Kinderspital
    • Ms.  PD Dr. med.  Bianca  Schaub 
    • Lindwurmstraße 4
    • 80337  München
    • Germany
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    • Dr. von Haunersches Kinderspital
    • Ms.  PD Dr. med.  Bianca  Schaub 
    • Lindwurmstraße 4
    • 80337  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.