Families-At-risk for Interstitial Lung Disease Study (NCT03641742) | Clinical Trial Compass
CompletedNot Applicable
Families-At-risk for Interstitial Lung Disease Study
United States125 participantsStarted 2018-01-15
Plain-language summary
The interstitial lung diseases (ILDs) are a family of closely related lung conditions characterized by alveolar inflammation, injury, and fibrosis not due to infection or neoplasia. While previously considered to be rare, a recent nationwide study found that idiopathic pulmonary fibrosis (IPF), a fibrotic ILD with a median survival of only 3.8 years, affects nearly 0.5% of older adults in the U.S. While pirfenidone and nintedanib slow the progression of IPF, neither reverses fibrosis nor prevents progression of the disease,and no studies to date have tested interventions that prevent the development of fibrotic ILDs.
Who can participate
Age range
35 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: For "At Risk" participants without clinical ILD
* Age 35 years or older, however subjects who are 40 years old and above will undergo HRCT and subjects age 40-65 years old will be eligible to undergo bronchoscopy
* First-degree relative with one of the following clinical diagnoses:
* Idiopathic Pulmonary Fibrosis
* Idiopathic Non-Specific Interstitial Lung Disease (with fibrosis)
* Chronic Hypersensitivity Pneumonitis (with fibrosis)
* Unclassifiable Idiopathic Interstitial Pneumonia (with fibrosis)
* Patients with any ILD characterized by fibrosis on CT chest scan
* Ability to provide informed consent
Inclusion Criteria: For "At Risk Smoker" participants without clinical ILD
* At least 50 years of age
* Smoked at least 1 pack a day for 30 years
Exclusion Criteria: For "At-Risk" participants without clinical ILD
* Known history of interstitial lung disease
* History of illicit drug use within the past year.
* Lower respiratory tract infection in the past 90 days.
* History of chest CT scan in the past year.
* Known history of heart failure or chronic kidney or liver disease.
* Pregnancy or Lactation
Inclusion Criteria: For "Proband" participants with clinical ILD Age 18 years or older
* Has one of the following clinical diagnoses as per ATS guidelines:
* Idiopathic Pulmonary Fibrosis
* Idiopathic Non-Specific Interstitial Lung Disease (with fibrosis)
* Chronic Hypersensitivity Pneumonitis (with fibrosis)
* Unclassifiable Idiopathic Interstitial Pneu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With ILA (Interstitial Lung Abnormalities)