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

• Conditions: Sarcoidosis; Idiopathic Pulmonary Fibrosis; Pulmonary Healthy Controls; Interstitial Lung Disease; Non-specific Interstitial Pneumonia; Granulomatosis With Polyangiitis (Wegener's Disease)
• Interventions: Device: multiple breath washout tests; Device: impulse oscillometry; Device: body plethysmography

• Registration Number: NCT02827734
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• known or suspected interstitial lung disease

Exclusion Criteria

• pregnancy
• inability to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry	30 minutes
lung clearance index (LCI) as determined by multiple breath washout	30 minutes

Secondary Outcome Measures

Name	Time	Method
repeatability of lung clearance index (LCI)	30 minutes

Trial Locations

Locations (1)

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Deutschland, Germany