Advancing Prevention of Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

— APPLe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564183
• Other study ID #: 20-1739
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Rachel Warren
• Phone: 303-724-8569
• Email: rachel.warren[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• ILD
• IPF
• Pulmonary Fibrosis

Intervention

Other:
• Sample collection
Blood, Urine, Nail, Hair, Saliva, optional Stool
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
University of Colorado, Denver	Mayo Clinic, University of California, Los Angeles, University of Pennsylvania, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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