Trial document




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  DRKS00006040

Trial Description

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Title

Non-interventional study of the clinical course of mild to moderate IPF under therapy with Esbriet(R)

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Trial Acronym

AER plus

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The IPF (idiopathic pulmonary fibrosis) is a chronic progressive form of a pulmonary disease, which is characterised by scar tissue (fibrosis) in the lungs.
As of recently the medication Pirfenidone Esbriet(R)is available as the only approved medical treatment for mild to moderate IPF in adult patients.
In this study the clinical course of mild to moderate IPF in patients receiving Esbriet(R) will be documented.

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Brief Summary in Scientific Language

The idiopathic pulmonary fibrosis (IPF) is a chronic disease of unknown cause, whose main characteristic feature is a progressive cicatrization (fibrosis) of the lungs. The IPF is the most common form of a interstitial pulmonary disease with a high rate of morbidity and mortality (with an average life expectancy around three years after time of diagnosis).

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Organizational Data

  •   DRKS00006040
  •   2014/05/15
  •   [---]*
  •   no
  •   Approved
  •   161/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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

  •   Mild to moderate Idiopathic Pulmonary Fibrosis in adults
  •   J84.1 -  Other interstitial pulmonary diseases with fibrosis
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Interventions/Observational Groups

  •   Observation of the application of Esbriet(R) (Pirfenidone) in the treatment of mild to moderate IPF in adult patients.
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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

Clinical outcome of patients suffering from a mild till moderate IPF after a one-year-therapie with Pirfenidon. The evaluation of the clinical outcome takes place by capturing and evaluating lung function parameters, blood gas analysis and others.

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Secondary Outcome

not specified/N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/07/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

According to SPMC

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Exclusion Criteria

According to SPMC

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Addresses

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    • InterMune Deutschland GmbH
    • Karl-Liebknecht-Str. 5
    • 10178  Berlin
    • Germany
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    • Onkodatamed GmbH
    • Ms.  Andrea  Lockner 
    • Friedenstrasse 58
    • 15366   Neuenhagen
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen
    • Germany
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Sources of Monetary or Material Support

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    • InterMune Deutschland GmbH
    • Karl-Liebknecht-Str. 5
    • 10178  Berlin
    • 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.