Trial document





This trial has been registered retrospectively.
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  DRKS00004914

Trial Description

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Title

Post-infectious reprogramming and its association with persistence and chronicity of respiratory allergic diseases

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Trial Acronym

PreDicta-WP1

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URL of the Trial

http://www.molekulare-pneumologie.uk-erlangen.de/e1846/e228/index_ger.html

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Brief Summary in Lay Language

Allergic asthma is a chronic inflammatory disease of the airways. There are two different types of this disease: the allergic and the non-allergic asthma. Additionally, it is known that virus infections – especially those caused by the humane rhinovirus – are the most frequent reasons for the acute aggravation of allergic asthma. Different factors can induce asthma in small children. These factors are genetic or environmentally determined . The latter component is often due to bacteria or viruses infections of the airways. The main purpose of this study is to investigate the influence of virus infections on the process of the asthmatic trait and to associate it with the underlying changes in immune response.
In the PreDicta study there will be a group of 40 patients (asthma) and a control group of 20 children (no asthma) examined over a period of 24 months. At the beginning and at the end of this period the blood and the Nasal Faryngel Fluid of these children will be analyzed with different tests.

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Brief Summary in Scientific Language

To this aim, not-interventional observations will be performed in the group of patients with asthma (n = 40) and a control group (no asthma; n = 20) at 4 to 6 years of age over a period of 24 months monitored/accompanied. From these patients there will be taken biological materials (blood, nasal swabs). This study investigates the influence of viruses (rhinovirus) and bacteria, which colonize the airways of children, on the Immune-pathogenesis of allergic asthma, in the time period between kindergarten and the beginning of the school age. To identify disease-specific-markers important for the diagnosis of this disease, analysis of the gene expression from PBMC and other not-invasive procedures (for example exhaled breath condensate) at the two indicated time points will be analyzed which
a) allows an advanced characterization of the molecular phenotypes)
b) identifies the pathogenetical differences between the two entities (boy/girl, age specific habits)
c) brings findings about the stability of the characteristics in a time schedule related manner.

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Organizational Data

  •   DRKS00004914
  •   2013/05/16
  •   [---]*
  •   yes
  •   Approved
  •   4435, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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

  •   J45 -  Asthma
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Interventions/Observational Groups

  •   Arm 1 Children with Asthma:
    - after 0 and 24 months: Recruitment Informed consent Baseline Questionnaire, PFR, NO, Spirometry, blood sample, NPSwap, Training for cards, Free-Running Test, Skin Prick Test
    - after 6, 12 and 18 month: Follow-up Questionaire Upload Data, PFR, NO, Free-Running Test, NPSwap, Training for cards
    - after 3, 9, 15 and 21 months: Telephone questionnaire
    - If during 24-months follow-up period a child develops a respiratory tract infection/cold or an exacerbation of asthma or a symptom score according to the diary cards bigger or equal 4 or a decrease in FEV1>15% or PEF>30% the parent will be instructed to call the study centre and arrange a visit to the clinic within the next two days in order to arrange a FeNO-Test and a NPSwap. Blood will be taken to get serum. 4 - 6 weeks after the same test will be taken.
  •   Arm 1 Control Children:
    - after 0 and 24 months: Recruitment Informed consent Baseline Questionnaire, PFR, NO, Spirometry, blood sample, NPSwap, Training for cards, Free-Running Test, Skin Prick Test
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Characteristics

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

After 0 and 24 month Genexpression with Real-Time PCR and ELISA from blood-PBMC (Peripheral Blood Mononuclear Cell)

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Secondary Outcome

By each hospital visit Fractionated Exhaled NO (FeNO-Monitor)Measurement and daily FEV1 measurement by electronic spirometer, Microbiology Nasal Swabs (Collaboration Prof. Dr. Bogdan)

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Countries of Recruitment

  •   Germany
  •   Greece
  •   Finland
  •   Poland
  •   Belgium
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/09/26
  •   300
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Mild to moderate persistent severity according to updated International Guidelines
- Written informed consent from the child’s parents/guardian’s
- Gestational age 36 weeks or above
- A diagnosis of asthma within the last 2 years, confirmed by a doctor of the participating study centre
- 3 episodes in the preceding 12 month (1 in the last 6 months)
- The child is able to perform at least a Peak Expiratory Flow (PEF) maneuver
- The legal custodian has the verbal, writing and mental ability to understand the intent and character of the study
- Age 4-6 years (beginning at the day of the 4th birthday and ending at the day of the 6th birthday)

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Exclusion Criteria

- Severe/brittle asthma
- Children receiving immunotherapy
- More than 6 courses of oral steroids during the proceeding 12 months
- Other chronic respiratory diseases (CF, BPD, immunodeficiencies) except allergic rhinits
- other chronical diseases or permanent medical treatment except for allergic exzema

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Addresses

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    • Universitätsklinikum Erlangen Anästhesie / Molekulare Pneumologie
    • Ms.  Prof. Dr. Dr.  Susetta  Finotto 
    • Hartmannstraße 14
    • 91052  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen Anästhesie Abteilung Molekulare Pneumologie
    • Ms.  Prof. Dr. Dr.  Susetta  Finotto 
    • Hartmannstraße 14
    • 91052  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen Kinder- und Jugendklinik
    • Mr.  Prof. Dr.  Theodor  Zimmermann 
    • Loschgestraße 15
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • European Commission DG Research - Uni F06 CDMA 02/069
    • Mr.  Gergios  Zisimatos 
    • 1049  Brüssel
    • Belgium
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Erlangen Anästhesie Abteilung Molekulare Pneumologie
    • Ms.  Prof. Dr. Dr.  Susetta  Finotto 
    • Hartmannstraße 14
    • 91052  Erlangen
    • 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.