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Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)

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ClinicalTrials.gov Identifier: NCT02827734
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Universitätsmedizin Mannheim

Tracking Information
First Submitted Date June 30, 2016
First Posted Date July 11, 2016
Last Update Posted Date April 16, 2019
Study Start Date October 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2016)
  • lung clearance index (LCI) as determined by multiple breath washout [ Time Frame: 30 minutes ]
  • airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry [ Time Frame: 30 minutes ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02827734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 5, 2016)
repeatability of lung clearance index (LCI) [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Official Title Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Brief Summary Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges set by the complex pathophysiology of this heterogenous group. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various ILDs.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with indication for routine lung function testing
Condition
  • Pulmonary Healthy Controls
  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
  • Non-specific Interstitial Pneumonia
  • Sarcoidosis
  • Granulomatosis With Polyangiitis (Wegener's Disease)
Intervention
  • Device: multiple breath washout tests
  • Device: impulse oscillometry
  • Device: body plethysmography
Study Groups/Cohorts
  • interstitial lung disease
    patients with known or suspected ILD such as idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, sarcoidosis, granulomatosis with polyangiitis
    Interventions:
    • Device: multiple breath washout tests
    • Device: impulse oscillometry
    • Device: body plethysmography
  • pulmonary healthy controls
    patients without known or suspected pulmonary disease
    Interventions:
    • Device: multiple breath washout tests
    • Device: impulse oscillometry
    • Device: body plethysmography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 5, 2016)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • known or suspected interstitial lung disease

Exclusion Criteria:

  • pregnancy
  • inability to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Frederik Trinkmann, Dr. +496213833879 frederik.trinkmann@umm.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02827734
Other Study ID Numbers MBW-ILD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
Study Sponsor Universitätsmedizin Mannheim
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitätsmedizin Mannheim
Verification Date April 2019