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OpenTrials
Active, Not Recruiting

NCT Number: NCT04564183

Advancing Prevention of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

IPF Fibrosis ILD Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

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

questionnaires

Other

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

High resolution CT scan of the chest

Radiation

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.

Pulmonary Function Test

Diagnostic 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Mayo Clinic
  • University of California, Los Angeles
  • University of Pennsylvania
  • University of Texas

Registry information

Official study title

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

Acronym: APPLe

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2020
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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