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Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Outcomes Registry

This is an observational study, called a registry, for people with Idiopathic Pulmonary Fibrosis (IPF) or other chronic fibrosing Interstitial Lung Diseases (ILDs). The study is not testing a new treatment, but rather collecting information over time to better understand these conditions. Researchers want to learn about how IPF and other ILDs progress naturally, how doctors currently diagnose and treat them, and how they affect your quality of life. You may be able to join if you are 21 or older and have a new diagnosis of IPF (within 12 months) or a diagnosis of a non-IPF ILD. The study aims to enroll 3000 participants in total. Enrollment for new IPF patients is restarting in 2023-2024.

Study design
This is an observational registry study, not testing a specific intervention. It plans to enroll 3000 participants across approximately 50 sites.
What's involved
Data and samples will be collected from participants for approximately 3 to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Data collection will continue for approximately 3 to 5 years after you join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01915511

Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Recruiting
Not specifiedAges 21+Observational
Duke University
~3,000 participants
Updated 2026-08-12 on ClinicalTrials.gov

At a glance

Recruiting sites
39 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Data on natural history of IPF & non-IPF chronic fibrosing ILD
Measured over End of Study (3 years after last patient will be enrolled)
+4 more outcomes measured

Conditions

Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Explore related trials

Idiopathic Pulmonary FibrosisInterstitial Lung Disease

Where it's being run

47 sites across 27 states
North Carolina5
Texas5
California3
Illinois3
Ohio3
Florida2
Georgia2
Michigan2

Study leadership

  • Scott Palmer, MD · PRINCIPAL_INVESTIGATOR · Duke Clinical Research Institute, Duke University

Who to contact

Rosalia Blanco
[email protected]
919-660-0890
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing and able to provide informed consent
Established a new diagnosis (within 12 months) of IPF by the enrolling center.
Age 21 years or older, or
Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype during the last 24 months by the enrolling center that meets the following criteria:
Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and/or lung biopsy.
Progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs (8):
decline in FVC % predicted (% pred) based on ≥10% relative decline
decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator
decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator
decline in DLCO % pred based on≥ 10% relative decline
worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.

Exclusion

Malignancy, treated or untreated, other than skin or early -stage prostate cancer, within the past 5 years
Currently listed for lung transplantation at the time of enrollment
Currently enrolled in an interventional clinical trial at the time of enrollment in this registry
For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.

What this trial measures

  • Data on natural history of IPF & non-IPF chronic fibrosing ILDEnd of Study (3 years after last patient will be enrolled)

    Characterize and describe the natural history of patients with a recent confirmed diagnosis of IPF, with emphasis on demographics, co-morbidities, medications, and risks for disease progression or death.

  • Data on current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILDEnd of Study (3 years after last patient will be enrolled)

    Understand the current practice patterns for diagnosis of IPF \& non-IPF chronic fibrosing ILD

  • Data on impact of IPF & non- IPF chronic fibrosing ILD on patient quality of life.End of Study (3 years after last patient will be enrolled)

    Describe the impact of IPF \& non- IPF chronic fibrosing ILD on patient quality-of-life (QOL).

  • Blood samples for future research.End of Study (3 years after last patient will be enrolled)

    Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions.

  • HRCT images for future research (for non-IPF chronic fibrosing ILD, and new IPF patients cohort)End of Study (3 years after last patient will be enrolled)

    Collect longitudinal HRCT images for future research