Trial document




drksid header

  DRKS00011583

Trial Description

start of 1:1-Block title

Title

Phenotyping of lung sounds in interstitial lung disease

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of this study is to compare patients with idiopathic pulmonary fibrosis and idiopathic non-specific interstitial pneumonia in a stable disease phase.
By means of a software-based analysis of an acoustic computerized lung sound monitor specific phenotypes of interstitial lung diseases should be identified. Moreover we will collect data of lungfunction, laboratory data and the subjective cough frequency using the visual analogue scale.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011583
  •   2017/03/30
  •   [---]*
  •   yes
  •   Approved
  •   22/2017, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J84.1 -  Other interstitial pulmonary diseases with fibrosis
  •   J84.8 -  Other specified interstitial pulmonary diseases
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Analysis of patients with idiopathic pulmonary fibrosis with long-term auscultation over 24h. The analysis is done on expression and dissemination of cough.
  •   Analysis of patients with idiopathic idiopathic non-specific interstitial pneumonia with long-term auscultation over 24h. The analysis is done on expression and dissemination of cough.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The aim of this study is to examine with the device of computer-based lungsound analysis the coughing episodes for patients with interstitial lung diseases.
The measurement will take 24h. Following we will compare the number of coughing episodes for patients with idiopathic pulmonary fibrosis and idiopathic non-specific interstitial pneumonia.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Is there a correlation between the number of coughing episodes and other parameters (lungfunction, laboratory tests)?

How many patients with interstitial lung diseases show coughing episodes?

Is there a correlation between the assessment of the subjective cough frequency using the visual analogue scale and the computerized lung sound monitor?

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2017/03/30
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• interstitial lung diseases
• defined by the European Respiratory Society and the American Thoracic Society
• Classified in a interdisciplinary case conferences in one of these diseases:
-idiopathic pulmonary fibrosis
-idiopathic non-specific interstitial pneumonia
• no acute severe exacerbation
• signed informed consent
• Age: ≥18 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• age <18 years
• mental retardation
• no signed informed consent
• acute exacerbation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr.   Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Kliniken der Stadt Köln gGmbH
    • Ms.  Dr  Sarah  Schwarz 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Heinen und Löwenstein
    • Arzbacher Straße 80
    • 56130  Bad Ems
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.