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Advancing Prevention of Pulmonary Fibrosis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04564183
Acronym
APPLe
Enrollment
800
Registered
2020-09-25
Start date
2021-01-22
Completion date
2026-08-01
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ILD, IPF, Pulmonary Fibrosis

Brief 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.

Interventions

OTHERSample collection

Blood, Urine, Nail, Hair, Saliva, optional Stool

OTHERQuestionnaires

SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire

RADIATIONHigh 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_TESTPulmonary 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.

Sponsors

Mayo Clinic
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
University of Texas
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the ChestBaselineAll 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026