Database for Interstitial Lung Disease

Clinical Database for the Early Recognition of Pulmonary Parenchymal Involvement in Patients With Systemic Diseases Bearing a Risk for Interstitial Lung Disease

The purpose of this study is to establish a clinical database for patients bearing at risk for ILD (Interstitial Lung Disease) and to set up a prospective ILD Screening program for these patients.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases, Interstitial
• Intervention / Treatment: Diagnostic test: chest CT

• Study Type: Observational
• Enrollment (Anticipated): 412

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
    • Contact: Gabor Kovacs, MD; Phone Number: +43-316-385-80748; Email: gabor.kovacs@klinikum-graz.at
    • Contact: Katarina Zeder, MD; Email: katarina.zeder@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients (females and males; above 18 yrs) with a known systemic disease bearing a risk for ILD but without diagnosed ILD and patients (females and males; above 18 yrs) with diagnosed ILD.

Description

Inclusion Criteria:

• Age: ≥ 18 years
• patients with a known systemic disease bearing a risk for ILD
• signed informed consent (for prospective part)

Exclusion Criteria:

• Age < 18 years
• comorbidities severely limiting life-expectancy (e.g. severe cardiovascular conditions, malignant disease)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prospective patient cohort; patients who will undergo the prospective ILD Screening algorithm	Diagnostic test: chest CT; assessment of interstitial lung disease using chest CT
retrospective patient cohort; patients with diagnosed ILD	Diagnostic test: chest CT; assessment of interstitial lung disease using chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLCO%pred (carbon monoxide diffusing capacity) at time of ILD diagnosis	The investigators aim to assess DLCO% pred at time of ILD diagnosis in patients undergoing a ILD Screening algorithm and compare to the retrospective patient cohort with diagnosed ILD and the DLCO%pred at time of ILD diagnosis	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC%pred (Forced vital capacity) at time of ILD diagnosis	The investigators aim to assess FVC% pred at time of ILD diagnosis in patients undergoing a ILD Screening algorithm and compare to the retrospective patient cohort with diagnosed ILD and the FVC%pred at time of ILD diagnosis	5 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): January 31, 2026
• Study Completion (Anticipated): January 31, 2026

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 33-023 ex 20/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No