Trial document




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  DRKS00000632

Trial Description

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Title

Identification of exacerbation markers in chronic inflammatory airway diseases

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A hallmark of chronic inflammatory airway diseases (e.g. COPD (chronic obstructive pulmonary disease) or asthma) is the increased formation of pulmonary secretions. In this study it shall be investigated whether such secretions contain hitherto unknown disease specific substances with the help of which exacerbations can be diagnosed at an early stage such that therapeutic interventions can rapidly be initiated. In order to adress this question airway secretions of healthy subjects and of patients suffering either from inflammations of the upper airways or from chronic inflammatory airway diseases are isolated and analyzed.

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Brief Summary in Scientific Language

Globally, chronic inflammatory airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), are a frequent cause for morbidity and mortality with ever increasing incidence. Particular attributes of these disorders are an increased production of secretions accompanied by chronic cough as well as constrictions of the airways and reduced gas exchange which in turn result in respiratory distress for the affected patients. One of the most feared complications of chronic inflammatory airway diseases are exacerbations. They are mostly due to viral and bacterial infections and usually require immediate medical attention. Patients afflicted by moderate to severe forms of chronic inflammatory airway diseases suffer from 1-4 exacerbations per year. Dependent on the stage of the disorder, the severeness of the exacerbation, the age of the patient and the presence of relevant comorbitities the mortality of patients suffering from acute exacerbations can reach up to 59%. It is generally accepted that the prognosis improves the earlier medical measures are taken. A timely intervention, however, requires the availability of diagnostic tools with which an incipient exacerbation can be detected.
In the course of this study it will be investigated whether the sputum of patients suffering from chronic inflammatory airway diseases contains disease specific substances, so called markers, with the help of which incipient exacerbations can be diagnosed at an early stage such that therapeutic interventions can rapidly be initiated if need be. In order to address this question airway secretions from healthy subjects and from patients suffering either from infections of the upper airways or from chronic inflammatory airway diseases will be isolated and analyzed.

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Organizational Data

  •   DRKS00000632
  •   2011/04/04
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  •   yes
  •   Approved
  •   08-149, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   J45 -  Asthma
  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Patients suffering from chronic inflammatory airway diseases (asthma or COPD)
  •   Patients suffering from infections of the upper airways, in the absence of a chronic inflammatory airway disease
  •   Healthy individuals
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Characteristics

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

The composition of airway secretions from healthy individuals and patients suffering from infections of the upper airways or from chronic inflammatory airway diseases is analyzed and compared.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/04/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Status of the donor:

a) confirmed chronic inflammatory airway disease (asthma or COPD) or

b) infection of the upper airways in the absence of a chronic inflammatory airway disease or

c) healthy

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Exclusion Criteria

The patient is not able to give his/her informed consent. The patient is in any relationship of dependency with the participating institutions

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Addresses

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    • Forschungszentrum Borstel Laborgruppe Mukosaimmunologie
    • Mr.  Dr.  Andreas  Frey 
    • Parkallee 22
    • 23845  Borstel
    • Germany
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    • Forschungszentrum Borstel Laborgruppe Mukosaimmunologie
    • Mr.  Dr.  Andreas  Frey 
    • Parkallee 22
    • 23845  Borstel
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Forschungszentrum Borstel Laborgruppe Mukosaimmunologie
    • Mr.  Dr.  Andreas  Frey 
    • Parkallee 22
    • 23845  Borstel
    • Germany
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Sources of Monetary or Material Support

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    • Forschungszentrum Borstel Abteilung Pneumologie
    • Mr.  Prof.Dr.med.  Peter  Zabel 
    • Parkallee 35
    • 23845  Borstel
    • 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.