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NCT04564183 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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