NCT04535245

Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.

Detailed description

50 scleroderma patients without evidence of lung disease who have been seen by an NJH Rheumatologist will be invited to participate. They will have their medical records reviewed to determine eligibility and then perform hand held spirometry and LCI testing. This measures evidence of small airway airflow obstruction and requires normal breathing while first on room air followed by inhaling a gas mixture of 100% oxygen. The Oxygen concentration in exhaled breathing and the number of breaths needed to return to room air concentration of Oxygen will be analyzed by a computer. Medical information from the EMR will be recorded and placed in a secure database, REDCap, for statistical analysis to determine if LCI results or other clinical features are predictive of which Scleroderma patients are most likely to subsequently develop evidence of Interstitial Lung disease (ILD) based upon yearly phone call interviews and EMR record reviews within 5 years of baseline testing.

Conditions

• Scleroderma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LCI testing	all subjects will have LCI testing then contacted via a phone interview or EMR review yearly times 5 to determine if they have subsequently developed ILD

Timeline

• Start date: 2021-01-04
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2020-09-01
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States