Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Recruiting now

Conditions studied: Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

In brief

The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.

Key facts

Study ID: NCT01915511
Run by: Duke University
People needed: 3000
Starts: 2014-06-01
Expected to finish: 2031-01-01
Last updated by the study team: 2026-07-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
The relative decline for FVC % predicted is calculated using the formula:
Relative Decline= (FVC % Pred (Reference)-FVC % Pred (Screening))/(FVC % Pred (Reference))×100%, where FVC % Pred (Reference) is the greatest measurement of FVC % predicted in the 24 months prior to screening and FVC % Pred (Screening) is the measurement of FVC % predicted at screening.
The relative decline for DLCO % predicted is calculated using the formula:
Relative Decline= (DLCO % Pred (Reference)-DLCO % Pred (Screening))/(DLCO % Pred (Reference))×100%, Where DLCO % Pred (Reference) is the greatest measurement of DLCO % Pred in the 24 months prior to screening and DLCO % Pred (Screening) is the measurement of DLCO % Pred at screening

You may not qualify if…

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.

Where it is running

Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
University of Arizona — Tucson, Arizona, United States (enrolling)
University of California - Los Angeles — Los Angeles, California, United States (enrolling)
University of Southern California — Los Angeles, California, United States (enrolling)
Stanford University — Stanford, California, United States (enrolling)
University of Colorado — Aurora, Colorado, United States (enrolling)
Yale University — New Haven, Connecticut, United States (enrolling)
University of Florida — Gainesville, Florida, United States (enrolling)
University of South Florida — Tampa, Florida, United States (enrolling)
Emory University — Atlanta, Georgia, United States (enrolling)
Piedmont Healthcare — Austell, Georgia, United States (enrolling)
University of Chicago — Chicago, Illinois, United States (enrolling)
Northwestern University — Evanston, Illinois, United States (enrolling)
Loyola University Health System — Maywood, Illinois, United States (enrolling)
University of Texas Southwestern — Dallas, Texas, United States (enrolling)
Baylor University Medical Center at Dallas — Dallas, Texas, United States (enrolling)
Baylor College of Medicine — Houston, Texas, United States (enrolling)
Houston Methodist Lung Center — Houston, Texas, United States (enrolling)
The University of Texas Health Science Center At Houston — Houston, Texas, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Inova — Falls Church, Virginia, United States (enrolling)
Tulane University — New Orleans, Louisiana, United States (enrolling)
University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
Washington University — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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