Recruiting

Lung Clearance Index

Sponsor:

National Jewish Health

Code:

NCT04535245

Conditions

Scleroderma

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

LCI testing

Study Details

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.

Conditions

Scleroderma

Study ID

NCT04535245

Start date

Jan 4, 2021

Status verified date

Mar, 2023

Completion date

Jan 15, 2026

Anticipated

Primary completion date

Jan 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

LCI testing

LCI testing will be performed on all study subjects

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Richard T meehan, MD

303 3981-1475meehanr@njhealth.org

Mary Gill, RN

720 936-9619gillm@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Richard T Meehan, MD

303-398-1475meehanr@njhealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Mar 24, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by National Jewish Health on 2023-03-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.