Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

• ClinicalTrials.gov Identifier: NCT04535245
• Recruitment Status: Recruiting
• First Posted: September 1, 2020
• Last Update Posted: January 6, 2021
• Sponsor: National Jewish Health
• Information provided by (Responsible Party): Richard Meehan, National Jewish Health

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Scleroderma	Diagnostic Test: LCI testing

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD
• Actual Study Start Date: January 4, 2021
• Estimated Primary Completion Date: January 15, 2026
• Estimated Study Completion Date: January 15, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
LCI testing; LCI testing will be performed on all study subjects	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; Other Name: no drugs will be administered

Outcome Measures

Primary Outcome Measures :

1. The Utility of Lung Clearance Index Scores at predicting Interstitial Lung disease ( ILD) development within 5 years among Scleroderma patients without ILD. [ Time Frame: 5 years after baseline testing ]
   Lung clearance index values (LCI) will be measured from all Scleroderma patients at baseline (normal value is < 7 ). The LCI scores from the cohort of Scleroderma patients who subsequently develop ILD based upon physician review of the EMR or phone interviews will be compared to the LCI scores from those scleroderma patients who did not develop ILD. Statistical analysis of LCI scores between both cohorts will determine the potential clinical utility of this non-invasive measurement of lung function in identifying those scleroderma patients who are at greatest risk for the subsequent development of ILD so treatment can be initiated early in their disease before irreversible pulmonary fibrosis develops.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Scleroderma patients without lung disease

Criteria

Inclusion Criteria:

• Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
• age 21-75
• No evidence of Scleroderma related Lung disease (ILD)
• Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.

Exclusion Criteria:

• Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
• Patients with evidence of lung involvement based upon; Thoracic imaging, abnormal Pulmonary Function Tests (PFTs); Forced Vital Capacity( FVC), Forced Expiratory Volume in 1 second (FEV1) or a Diffusion Capacity for Carbon Monoxide (DLCO) < the Lower Limit of Normal (LLN) or Saturation of Oxygen in arterial blood (SaO2) < 90% .
• Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
• < 21 or > 75 years of age
• Must not be pregnant or had eye surgery within 2 weeks of LCI testing
• Must be able to comprehend and sign an IRB approved consent form and complete LCI testing

Contacts and Locations

Contacts

Contact: Richard T meehan, MD; 303 3981-1475; meehanr@njhealth.org

Contact: Mary Gill, RN; 720 936-9619; gillm@njhealth.org

Locations

United States, Colorado

National Jewish Health; Recruiting

Denver, Colorado, United States, 80206

Contact: Richard T Meehan, MD 303-398-1475 meehanr@njhealth.org

Sub-Investigator: Mehrnaz Maleki, MD

Sub-Investigator: Liudmila Kastsianok, MD

Sponsors and Collaborators

National Jewish Health

Investigators

• Principal Investigator: Richard T Meehan, MD; National Jewish Health

More Information

• Responsible Party: Richard Meehan, Professsor of Medicine, National Jewish Health
• ClinicalTrials.gov Identifier: NCT04535245
• Other Study ID Numbers: HS 3471
• First Posted: September 1, 2020
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Connective Tissue Diseases; Skin Diseases