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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

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.

Condition or disease Intervention/treatment
Pulmonary Healthy Controls Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Non-specific Interstitial Pneumonia Sarcoidosis Granulomatosis With Polyangiitis (Wegener's Disease) Device: multiple breath washout tests Device: impulse oscillometry Device: body plethysmography

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
interstitial lung disease
patients with known or suspected ILD such as idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, sarcoidosis, granulomatosis with polyangiitis
Device: multiple breath washout tests
Device: impulse oscillometry
Device: body plethysmography
pulmonary healthy controls
patients without known or suspected pulmonary disease
Device: multiple breath washout tests
Device: impulse oscillometry
Device: body plethysmography



Primary Outcome Measures :
  1. lung clearance index (LCI) as determined by multiple breath washout [ Time Frame: 30 minutes ]
  2. airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. repeatability of lung clearance index (LCI) [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with indication for routine lung function testing
Criteria

Inclusion Criteria:

  • known or suspected interstitial lung disease

Exclusion Criteria:

  • pregnancy
  • inability to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827734


Contacts
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Contact: Frederik Trinkmann, Dr. +496213833879 frederik.trinkmann@umm.de

Locations
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Germany
Universitätsmedizin Mannheim Recruiting
Mannheim, Deutschland, Germany, 68167
Contact: Frederik Trinkmann, Dr.    +496213833879    frederik.trinkmann@umm.de   
Principal Investigator: Frederik Trinkmann, Dr.         
Principal Investigator: Joachim Saur, Prof. Dr.         
Principal Investigator: Thomas Henzler, Prof. Dr.         
Sponsors and Collaborators
Universitätsmedizin Mannheim

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Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02827734     History of Changes
Other Study ID Numbers: MBW-ILD
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Granulomatosis with Polyangiitis
Sarcoidosis
Respiratory Tract Diseases
Respiratory Tract Infections
Lymphoproliferative Disorders
Lymphatic Diseases
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases