Trial document





This trial has been registered retrospectively.
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  DRKS00006046

Trial Description

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Title

Therapy monitoring of omalizumab in children and adolescents with severe allergic asthma

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The monoclonal anti-IgE antibody omalizumab is used as add-on therapy for improved asthma control in children and adolescents with severe persistent allergic bronchial asthma. The aim of the study was to examine the effectiveness of omalizumab and to demonstrate the hitherto unavailable possibilities for treatment monitoring by means of a bed-side immunoassay. In the prospective longitudinal study patients aged 6 to 18 years with severe persistent allergic asthma received add-on treatment with omalizumab. Besides the parameters of general physical examination, recordings of exacerbation rate, asthma control and lung function (FEV1), total IgE concentrations in serum were determined after 6 and 12 months; free IgE was measured using immunoassays.

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Brief Summary in Scientific Language

Therapeutic antibodies have become increasingly important in the treatment of diseases with inflammatory background. Omalizumab has been used successfully for years in Germany as add-on therapy for improved asthma control in children over 6 years of age with severe persistent allergic bronchial asthma. Omalizumab is a monoclonal anti-IgE antibody that binds to circulating IgE molecules and suppresses the expression of the high-affinity IgE receptor on mast cells, basophilic granulocytes and other immune effector cells. The dosage and dose frequency are guided by the total serum IgE and the patient’s weight prior to the onset of treatment. The largely schematic administration leaves little room for individualised therapy. Until now, only the reduction in asthma symptoms and improved asthma control have been important for assessing the course of the disease in patients on Omalizumab therapy. Thus, routine diagnostic tests to measure free serum IgE together with a thourough clinical examination would allow an individualized therapy minimizing costs and patients’ medicinal burden.
The aim of the study was to examine the effectiveness of omalizumab and to demonstrate the hitherto unavailable possibilities for treatment monitoring by means of a bed-side immunoassay. In the prospective longitudinal study patients aged 6 to 18 years with severe persistent allergic asthma received add-on treatment with omalizumab. Besides the parameters of general physical examination, recordings of exacerbation rate, asthma control and lung function (FEV1), total IgE concentrations in serum were determined after 6 and 12 months; free IgE was measured using immunoassays.

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Organizational Data

  •   DRKS00006046
  •   2014/04/01
  •   [---]*
  •   yes
  •   Approved
  •   80/11, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   J45.0 -  Predominantly allergic asthma
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Interventions/Observational Groups

  •   open-descriptive-not interventional-oberservational study.
    In a prospective longitudinal study patients aged 6 to 18 years with severe persistent allergic asthma received add-on treatment with omalizumab. Bedsides the parameters of general physical examination, recordings of exacerbation rate, asthma control and lung function (FEV1), total IgE concentrations in serum and free IgE were measured with special immunassays.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Total IgE and free IgE concentrations in serum were determined after 6 and 12 months (Sandwich-Immunassay)

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Secondary Outcome

Recordings of exacerbation rate, asthma control and lung function (FEV1) determined after 6 and 12 months start the omalizumab therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/05/02
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

severe allergic asthma
> 6 years of age
<18 years of age
informed consent of the patients and their parents

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Exclusion Criteria

no severe allergic asthma
< 6 years of age
> 18 years of age

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Addresses

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    • Universitätsklinikum Gießen und Marburg
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Universitätsklinikum Gießen und Marburg
    • Mr.  PD Dr.med.  Jens-Oliver  Steiß 
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Universitätsklinikum Gießen und Marburg
    • Mr.  PD Dr.med.  Jens-Oliver  Steiß 
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Kinderheilkunde und JugendmedizinUniversitätsklinikum Gießen und Marburg GmbHPädiatrische Pneumologie udn Allergologie
    • Mr.  PD D.med.  Jens-Oliver  Steiß 
    • Feulgenstraße 12
    • 35385  Gießen
    • 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.