Advancing Prevention of Pulmonary Fibrosis (APPLe)

Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Fibrosis; IPF; ILD
• Intervention / Treatment: Other: Sample collection; Other: Questionnaires; Radiation: High resolution CT scan of the chest; Diagnostic test: Pulmonary Function Test

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Emily Culbertson; Phone Number: 303-724-4025; Email: emily.culbertson@cuanschutz.edu
• Study Contact Backup: Name: Rachel Warren; Phone Number: 303-724-8569; Email: rachel.warren@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Rachel Warren, BA; Phone Number: 303-724-8569; Email: rachel.warren@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Full Cohort; Entire study population	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.
Sub-Cohort; Randomly selected sub-cohort from the larger group of all participants	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Mayo Clinic; University of Pennsylvania; University of California, Los Angeles; University of Texas
• Investigators: Principal Investigator: David Schwartz, MD, University of Colorado School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: 20-1739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No