Using Lung Clearance Index to Identify Scleroderma Patients at Risk for Lung Disease
Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD
This study is trying to see if a lung test can help find scleroderma patients who might develop lung disease in the future, even if they don't have any symptoms right now.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | National Jewish Health Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT04535245 on ClinicalTrials.gov |
What this trial studies
This observational pilot study at National Jewish Health aims to assess the Lung Clearance Index (LCI) in 50 scleroderma patients who currently show no signs of lung disease. Participants will undergo non-invasive lung function tests, including hand-held spirometry and LCI testing, to evaluate small airway function. The study will track these patients over five years through phone interviews and electronic medical record reviews to determine if LCI results can predict the development of interstitial lung disease (ILD) or pulmonary artery hypertension. The data collected will be analyzed to identify clinical features associated with increased risk for these conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-75 with a confirmed diagnosis of systemic sclerosis and no current evidence of lung disease.
Not a fit: Patients with existing lung involvement or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify scleroderma patients at higher risk for developing serious lung complications, allowing for earlier intervention.
How similar studies have performed: While similar studies have explored lung function in scleroderma, this specific approach using LCI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- National Jewish Health — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Richard T Meehan, MD — National Jewish Health
- Study coordinator: Richard T meehan, MD
- Email: meehanr@njhealth.org
- Phone: 303 3981-1475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.