Advancing Prevention of Pulmonary Fibrosis

Study Purpose

This study plans to learn more about pulmonary fibrosis and how it develops. We want to understand if the disease can be found early, before the lung is permanently scarred. This study will create a cohort, or group, of participants who are not currently diagnosed with pulmonary fibrosis, but who all have family members with pulmonary fibrosis. The cohort will allow us to learn how pulmonary fibrosis develops, and to learn how the lungs change over time in people with and without pulmonary fibrosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
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 - 89 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- First degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP) - Age at least 40 years old and younger than 90 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 Not yet recruiting
Countries
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, Buccal Brush

Other: - Questionnaires

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

Radiation: - High resolution CT scan of the chest

All patients will undergo single prone volumetric thoracic chest CT scans performed at full inspiration using a 64-slice CT scanner at baseline.

Diagnostic Test: - Pulmonary Function Test

All recruited subjects will complete measurements of pre-bronchodilator spirometry and a measurement of diffusion capacity in accordance with ATS guidelines. Exercise capacity will be assessed by performing a 6-minute walk test, according to ATS guidelines.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Rachel Warren

rachel.warren@cuanschutz.edu

303-724-8569

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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