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

NCT02827734 | Unknown DMC

• 1 other identifier: MBW-ILD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Healthy Controls; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Non-specific Interstitial Pneumonia; Sarcoidosis; Granulomatosis With Polyangiitis (Wegener's Disease)

Outcome Measures

Primary Outcomes (2)

• lung clearance index (LCI) as determined by multiple breath washout

  30 minutes

• airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry

  30 minutes

Secondary Outcomes (1)

• repeatability of lung clearance index (LCI)

  30 minutes

Study Arms (2)

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

Interventions

multiple breath washout tests DEVICE

interstitial lung disease; pulmonary healthy controls

impulse oscillometry DEVICE

interstitial lung disease; pulmonary healthy controls

body plethysmography DEVICE

interstitial lung disease; pulmonary healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with indication for routine lung function testing

You may qualify if:

• known or suspected interstitial lung disease

You may not qualify if:

• pregnancy
• inability to participate

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Universitätsmedizin Mannheim

Mannheim, Deutschland, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Sarcoidosis; Granulomatosis with Polyangiitis

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Central Study Contacts

Frederik Trinkmann, Dr.

CONTACT

+496213833879; frederik.trinkmann@umm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)