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Advancing Prevention of Pulmonary Fibrosis

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	40 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04564183
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Schwartz, MD
Principal Investigator Affiliation	University of Colorado School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	IPF, Pulmonary Fibrosis, ILD

Arms & Interventions

Arms

: Full Cohort

Entire study population

: Sub-Cohort

Randomly selected sub-cohort from the larger group of all participants

Interventions

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 patients 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 subjects 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Site Contact

Rachel Warren, BA

rachel.warren@cuanschutz.edu

303-724-8569