Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry (IPF/ILD-PRO)

May 5, 2026 updated by: Duke University

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (IPF-PRO/ILD-PRO) Registry

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This registry originally enrolled a total of 1002 participants newly diagnosed with IPF and continues to enroll patients with other chronic fibrosing ILDs with newly identified progressive phenotype to reach an enrollment of 1000 patients. Participants will be enrolled in three phases, (IPF-PRO and ILD-PRO) over a span of 8 years at approximately 50 sites experienced in the diagnosis and treatment of ILD in the United States. Enrollment for the original IPF cohort started in 2014 and ended in October 2018, with 1002 total participants enrolled. In the third phase of the registry new enrollment for patients with IPF will restart in 2023-2024 with the plan to enroll up to 1000 new IPF patients, for a total IPF enrollment of 2000. Enrollment for other chronic fibrosing ILDs with newly identified progressive phenotype cohort was initiated in February 2019 and will end when enrollment reaches 1000 participants with the potential of enrolling another 1000 participants with other chronic fibrosing ILDs with newly identified without a progressive phenotype. Data and samples will be collected from participants for approximately 5 years for the IPF cohort. For the chronic fibrosing ILD with progressive phenotype cohort, data and samples will be collected for a minimum of 3 years, up to approximately 5 years. Participant management and treatment decisions will be determined by participants and their health care professionals.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama - Birmingham
        • Principal Investigator:
          • Tejaswini Kulkarni, MD
        • Contact:
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Sally A Suliman, MD
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Toby Maher, MD
      • Los Angeles, California, United States, 90024
        • Recruiting
        • University of California - Los Angeles
        • Principal Investigator:
          • John Belperio, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Rishi Raj, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Joyce Lee, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Mridu Gulati, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610-3175
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Jose D Herazo-Maya, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Srihari Veeraraghavan, MD
      • Austell, Georgia, United States, 30106
        • Recruiting
        • Piedmont Healthcare
        • Principal Investigator:
          • Amy Case, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Mary Strek, MD
        • Contact:
      • Evanston, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Bradford Bemiss, MD
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Health System
        • Principal Investigator:
          • Daniel Dilling, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • University of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University
        • Principal Investigator:
          • Joe Lasky, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Hyum Kim, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Kimberly Dobbs, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Tonya Russell, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Medical College of Cornell University
        • Principal Investigator:
          • Kerri Aronson, MD
        • Contact:
      • New York, New York, United States, 10016
        • Active, not recruiting
        • NYU Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Lake Morrison, MD
        • Contact:
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • PulmonIx LLC
        • Principal Investigator:
          • Murali Ramaswamy, MD
        • Contact:
      • Wilmington, North Carolina, United States, 28401
        • Active, not recruiting
        • PMG Research
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health
        • Contact:
        • Principal Investigator:
          • Andrew Namen, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Active, not recruiting
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Briam Southern, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • John Odackal
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Contact:
        • Principal Investigator:
          • Jad Kebbe, MD
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • Oregon Clinic
        • Principal Investigator:
          • David Hotchkin, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Timothy Whelan, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Justin Hewlett, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern
        • Principal Investigator:
          • John Fitzgerald, MD
        • Contact:
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center at Dallas
        • Principal Investigator:
          • Yolanda Mageto, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Ivan Rosas, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Rodeo Abrencillo, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Lung Center
        • Contact:
        • Principal Investigator:
          • Zeenat Safdar, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Mary Beth Langer, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Active, not recruiting
        • University from Virginia
      • Falls Church, Virginia, United States, 22042-3307
        • Recruiting
        • Inova
        • Contact:
        • Principal Investigator:
          • Jared Wilkinson, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • The Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with a new diagnosis of IPF or a non- IPF chronic fibrosing ILD established at the time of enrollment in the registry are eligible for participation in the IPF-PRO/ILD-PRO registry if the participant meets the selection criteria.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry
Subjects with a non-IPF ILD diagnosis
Subjects with a 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
New Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry not previously enrolled in the registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data on natural history of IPF & non-IPF chronic fibrosing ILD
Time Frame: End 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.
End of Study (3 years after last patient will be enrolled)
Data on current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD
Time Frame: End of Study (3 years after last patient will be enrolled)
Understand the current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD
End of Study (3 years after last patient will be enrolled)
Data on impact of IPF & non- IPF chronic fibrosing ILD on patient quality of life.
Time Frame: 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).
End of Study (3 years after last patient will be enrolled)
Blood samples for future research.
Time Frame: 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.
End of Study (3 years after last patient will be enrolled)
HRCT images for future research (for non-IPF chronic fibrosing ILD, and new IPF patients cohort)
Time Frame: End of Study (3 years after last patient will be enrolled)
Collect longitudinal HRCT images for future research
End of Study (3 years after last patient will be enrolled)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data on management practices compared to existing guidelines.
Time Frame: End of Study (3 years after last patient will be enrolled)
Compare disease-specific management practices with existing guidelines.
End of Study (3 years after last patient will be enrolled)
Data on center-specific practices on outcomes.
Time Frame: End of Study (3 years after last patient will be enrolled)
Determine the influence of center-specific practices on patient outcomes.
End of Study (3 years after last patient will be enrolled)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Boehringer Ingelheim

Investigators

  • Principal Investigator: Scott Palmer, MD, Duke Clinical Research Institute, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimated)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00046131
  • 1199.174 (Other Identifier: DCRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe