Advancing Prevention of Pulmonary Fibrosis

Overview

This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred. This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.

Full Title of Study: “Advancing Prevention of Pulmonary Fibrosis – A Cohort Study of Preclinical Pulmonary Fibrosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2024

Interventions

  • Other: Sample collection
    • Blood, Urine, Nail, Hair, Saliva, optional Stool
  • Other: Questionnaires
    • SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire
  • Radiation: High resolution CT scan of the chest
    • Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.
  • Diagnostic Test: Pulmonary Function Test
    • All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.

Arms, Groups and Cohorts

  • Full Cohort
    • Entire study population
  • Sub-Cohort
    • Randomly selected sub-cohort from the larger group of all participants

Clinical Trial Outcome Measures

Primary Measures

  • Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest
    • Time Frame: Baseline
    • All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.

Participating in This Clinical Trial

Inclusion Criteria

  • Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP) – Age at least 40 years old and younger than 75 years old Exclusion Criteria:

  • Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent – Other genetic diseases associated with interstitial lung disease – Pregnant women

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Schwartz, MD, Principal Investigator, University of Colorado School of Medicine
  • Overall Contact(s)
    • Rachel Warren, 303-724-8569, rachel.warren@cuanschutz.edu

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