Trial document





This trial has been registered retrospectively.
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  DRKS00010531

Trial Description

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Title

Comparison of nasal and bronchial house dust mite (HDM) provocation in childhood.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To demonstrate the relevance of mite allergy a bronchial provocation test routinely will be performed. This test is often positive, but also in 20 % of cases negative. A nasal provocation test
should be performed to demonstrate the relevance of mite allergy in the nose.
In the proposed study , the validity and comparability of both challenges will be investigated to characterize different allergy symptoms in the nose and lung in children and adolescents.

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Brief Summary in Scientific Language

The aim of this study is to compare the nasal and bronchial allergen challenge in children and adolescents with mite allergy. So far, bronchial allergen challenge is the gold standard to examine the relevance of mite allergy before the start of a specific immunotherapy. The comparability of both test methods is unclear and will be investigated in this study. In addition, the Serum IgE will be compared to the nasal IgE and correlated to the results of the bronchial and nasal allergen challenge.

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Organizational Data

  •   DRKS00010531
  •   2016/05/27
  •   [---]*
  •   yes
  •   Approved
  •   357/14, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   J30.3 -  Other allergic rhinitis
  •   J45.0 -  Predominantly allergic asthma
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Interventions/Observational Groups

  •   Patients with a positive skin prick test after bronchial allergen challenge will be asked to participate in the study. Within 12 weeks, the patient will be reinvited for the second visit. Then a physical examination and a standardized questionnaire will be performed before nasal allergen challenge with HDM.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

The Primary endpoint is the concordance of the nasal and bronchial allergen challenge for the grading negative, moderate and severe allergic reaction

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Secondary Outcome

Correlation of peak nasal inspiratory flow and nasal symptoms to the lokal and serum IgE.
Comparison of the IgE repertoire (epitope spectrum) nasal vs. serum IgE.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/01/05
  •   65
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   24   Years
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Additional Inclusion Criteria

Diagnosis of mite allergy (skin prick test ≥ 3mm)
Known asthma and / or allergic rhinoconjunctivitis
Bronchial allergen challenge performed in the preceding 12 weeks
exacerbation free interval> 4 weeks before visit 1
Written informed consent of the parents and the child / adolescent

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Exclusion Criteria

Age <5 years, age> 25 years
Exacerbation of asthma within the last 28 days
Severe symptoms of allergic rhinitis or relevant deterioration of allergic symptoms
Intake of the following drugs before testing: Decongestant nose drops one day, antihistamines three days, nasal steroids 14 days, oral cortisone four weeks, leukotriene antagonists and cromoglycic acid three days before nasal provocation challenge.
Adenoids or nasal surgery in the last three months
Serious deviation of the nasal septum
Other serious diseases (for example, cystic fibrosis, diseases with immunosuppression, malignancies)
Pregnancy, lactation
Participation in another clinical trial <30 days
Inability to understand the scope of the study





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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Mr.  Prof.  Stefan  Zielen 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Ms.  Dr.  Anna  Buslau 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinik für Kinder- und Jugendmedizin
    • Ms.  Dr.  Anna  Buslau 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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.