Trial document




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  DRKS00000117

Trial Description

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Title

Non-Eosinophilic vs. eosinophilic asthma: phenotypical characteristics and gene expression

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

There are different subtypes of the disease Asthma (eosinophilic vs. non-eosinophilic). Two groups of asthmatic patients that have not been treated yet will be observed for 8 weeks. At the beginning and at the end of this period of time a number of diagnostic procedures are planned to describe the subtypes of this disease in detail.

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Brief Summary in Scientific Language

This is a non-interventional observational study. Two groups of asthmatic patients (n = 20) are to be observed for a period of 8 weeks. Blood and BAL will be collected at the beginning (before treatment) and at the end (on treatment with ICS) of 8 weeks. By analyzing gene expression in lymphocytes and by non-invasive procedures (EBC, electronic nose) we will try to identifiy disease-specific patterns
a) to characterize both phenotypes
b) to identify pathogenetic differences of both phenotypes
c) to gain insight into the natural course of both phenotypes

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Organizational Data

  •   DRKS00000117
  •   2009/04/17
  •   [---]*
  •   yes
  •   Approved
  •   Az 155/08, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   Asthma
  •   J45.0 -  Predominantly allergic asthma
  •   J45.1 -  Nonallergic asthma
  •   J45 -  Asthma
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Interventions/Observational Groups

  •   No intervention
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Gene expression in lymphocytes (Affymetrix HGO 133+2.0 Arrays)

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Secondary Outcome

FeNO, induced sputum, exhaled breath condensate, electronic nose

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/07/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Diagnosis of Asthma according to GINA guidelines

- Reversible airway obstruction (FEV1 > 12 % and 200 ml) post 400 µl Salbutamol

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Exclusion Criteria

- COPD or any other disease of the respiratory system (except athma)
- Respiratory tract infections within 30 days before timepoint -1
- Systemic or inhaled corticosteroids within 3 months prior before timepoint -1
- Non-stable phenotype regarding sputum-eosinophilia at timepoint 0
- Beta-blocker
- Active smoking or ex-smoking for less than 1 year
- Smoking > 1 packyear
- Significant diseases other than asthma. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because
of participation in the study.
- Planned hospitalization during the course of the study
- Any clinically relevant abnormal result (lab or clincal) at the timepoints -1 and 0
- Patients who are currently participating in another study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Koordinierungszentrum für Klinische Studien der Philipps Universität Marburg
    • Ms.  Carmen  Schade-Brittinger 
    • Karl-von-Frisch-Straße 4
    • 35043  Marburg
    • Germany
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    • UKGM Marburg
    • Mr.  Prof. Dr. med.  Claus  Vogelmeier 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • UKGM Marburg
    • Mr.  Dr. med.  Timm  Greulich 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • DFG - Deutsche Forschungsgemeinschaft
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.