Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
NCT ID: NCT01915511
Last Updated: 2025-10-14
Study Results
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Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2014-06-30
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry
No interventions assigned to this group
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
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Scott Palmer, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute, Duke University
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare
Austell, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Loyola University Health System
Maywood, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
University from Virginia
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
NYU Medical Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Pulmonix LLC
Greensboro, North Carolina, United States
PMG Research
Wilmington, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Clinic
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor University Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Lung Center
Houston, Texas, United States
Inova
Falls Church, Virginia, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Menon AA, Gansen B, Mulder H, Neely ML, Papavasileiou P, Salisbury ML, Southern BD, Hesslinger C, Leonard TB, Meissner F, Todd JL. Mass spectrometry-based peripheral blood proteomics for biomarker discovery in idiopathic pulmonary fibrosis. Respir Res. 2025 Oct 22;26(1):294. doi: 10.1186/s12931-025-03377-5.
Swaminathan AC, Weber JM, Todd JL, Palmer SM, Neely ML, Whelan TP, Kim GHJ, Leonard TB, Goldin J. Extent of lung fibrosis is of greater prognostic importance than HRCT pattern in patients with progressive pulmonary fibrosis: data from the ILD-PRO registry. Respir Res. 2025 Feb 28;26(1):73. doi: 10.1186/s12931-025-03136-6.
Oldham JM, Neely ML, Wojdyla DM, Gulati M, Li P, Patel DC, Palmer SM, Todd JL; IPF-PRO Registry Investigators. Changes in Lung Function and Mortality Risk in Patients With Idiopathic Pulmonary Fibrosis. Chest. 2025 Aug;168(2):415-422. doi: 10.1016/j.chest.2025.02.018. Epub 2025 Feb 26.
Sack C, Wojdyla DM, MacMurdo MG, Gassett A, Kaufman JD, Raghu G, Redlich CA, Li P, Olson AL, Leonard TB, Todd JL, Neely ML, Snyder LD, Gulati M; IPF-PRO Registry investigators. Long-Term Air Pollution Exposure and Severity of Idiopathic Pulmonary Fibrosis: Data from the Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry. Ann Am Thorac Soc. 2025 Mar;22(3):378-386. doi: 10.1513/AnnalsATS.202404-382OC.
Wang L, Wu P, Liu Y, Patel DC, Leonard TB, Zhao H. Clustering-aided prediction of outcomes in patients with idiopathic pulmonary fibrosis. Respir Res. 2024 Oct 23;25(1):383. doi: 10.1186/s12931-024-03015-6.
Lobo LJ, Liu Y, Li P, Ramaswamy M, Swaminathan AC, Veeraraghavan S, Fan Y, Neely ML, Palmer SM, Olson AL; ILD-PRO Registry investigatorsdagger. Design and baseline characteristics of the ILD-PRO registry in patients with progressive pulmonary fibrosis. BMC Pulm Med. 2024 Sep 27;24(1):468. doi: 10.1186/s12890-024-03247-8.
Summer R, Todd JL, Neely ML, Lobo LJ, Namen A, Newby LK, Shafazand S, Suliman S, Hesslinger C, Keller S, Leonard TB, Palmer SM, Ilkayeva O, Muehlbauer MJ, Newgard CB, Roman J. Circulating metabolic profile in idiopathic pulmonary fibrosis: data from the IPF-PRO Registry. Respir Res. 2024 Jan 25;25(1):58. doi: 10.1186/s12931-023-02644-7.
Neely ML, Hellkamp AS, Bender S, Todd JL, Liesching T, Luckhardt TR, Oldham JM, Raj R, White ES, Palmer SM. Lung function trajectories in patients with idiopathic pulmonary fibrosis. Respir Res. 2023 Aug 24;24(1):209. doi: 10.1186/s12931-023-02503-5.
Ruan P, Todd JL, Zhao H, Liu Y, Vinisko R, Soellner JF, Schmid R, Kaner RJ, Luckhardt TR, Neely ML, Noth I, Porteous M, Raj R, Safdar Z, Strek ME, Hesslinger C, Palmer SM, Leonard TB, Salisbury ML. Integrative multi-omics analysis reveals novel idiopathic pulmonary fibrosis endotypes associated with disease progression. Respir Res. 2023 May 31;24(1):141. doi: 10.1186/s12931-023-02435-0.
Swaminathan AC, Hellkamp AS, Neely ML, Bender S, Paoletti L, White ES, Palmer SM, Whelan TPM, Dilling DF; Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry investigators. Disparities in Lung Transplant among Patients with Idiopathic Pulmonary Fibrosis: An Analysis of the IPF-PRO Registry. Ann Am Thorac Soc. 2022 Jun;19(6):981-990. doi: 10.1513/AnnalsATS.202105-589OC.
Kim HJ, Snyder LD, Neely ML, Hellkamp AS, Hotchkin DL, Morrison LD, Bender S, Leonard TB, Culver DA; IPF-PRO Registry investigators. Clinical Outcomes of Patients with Combined Idiopathic Pulmonary Fibrosis and Emphysema in the IPF-PRO Registry. Lung. 2022 Feb;200(1):21-29. doi: 10.1007/s00408-021-00506-x. Epub 2022 Jan 7.
de Andrade JA, Kulkarni T, Neely ML, Hellkamp AS, Case AH, Culver DA, Guntupalli K, Bender S, Conoscenti CS, Snyder LD; IPF-PRO Registry Investigators. Associations between resources and practices of ILD centers and outcomes in patients with idiopathic pulmonary fibrosis: data from the IPF-PRO Registry. Respir Res. 2022 Jan 7;23(1):3. doi: 10.1186/s12931-021-01921-7.
Kim HJ, Snyder LD, Adegunsoye A, Neely ML, Bender S, White ES, Conoscenti CS, Strek ME; IPF-PRO Registry Investigators. Hospitalizations in patients with idiopathic pulmonary fibrosis. Respir Res. 2021 Sep 30;22(1):257. doi: 10.1186/s12931-021-01851-4.
Salisbury ML, Conoscenti CS, Culver DA, Yow E, Neely ML, Bender S, Hartmann N, Palmer SM, Leonard TB; IPF-PRO Registry principal investigators as follows. Antifibrotic Drug Use in Patients with Idiopathic Pulmonary Fibrosis. Data from the IPF-PRO Registry. Ann Am Thorac Soc. 2020 Nov;17(11):1413-1423. doi: 10.1513/AnnalsATS.201912-880OC.
Fan Y, Bender SD, Conoscenti CS, Davidson-Ray L, Cowper PA, Palmer SM, de Andrade JA; IPF-PRO Registry Investigators. Hospital-Based Resource Use and Costs Among Patients With Idiopathic Pulmonary Fibrosis Enrolled in the Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry. Chest. 2020 Jun;157(6):1522-1530. doi: 10.1016/j.chest.2019.12.041. Epub 2020 Jan 29.
O'Brien EC, Hellkamp AS, Neely ML, Swaminathan A, Bender S, Snyder LD, Culver DA, Conoscenti CS, Todd JL, Palmer SM, Leonard TB; IPF-PRO Registry investigators. Disease Severity and Quality of Life in Patients With Idiopathic Pulmonary Fibrosis: A Cross-Sectional Analysis of the IPF-PRO Registry. Chest. 2020 May;157(5):1188-1198. doi: 10.1016/j.chest.2019.11.042. Epub 2020 Jan 15.
Todd JL, Neely ML, Overton R, Durham K, Gulati M, Huang H, Roman J, Newby LK, Flaherty KR, Vinisko R, Liu Y, Roy J, Schmid R, Strobel B, Hesslinger C, Leonard TB, Noth I, Belperio JA, Palmer SM; IPF-PRO Registry investigators. Peripheral blood proteomic profiling of idiopathic pulmonary fibrosis biomarkers in the multicentre IPF-PRO Registry. Respir Res. 2019 Oct 22;20(1):227. doi: 10.1186/s12931-019-1190-z.
Snyder L, Neely ML, Hellkamp AS, O'Brien E, de Andrade J, Conoscenti CS, Leonard T, Bender S, Gulati M, Culver DA, Kaner RJ, Palmer S, Kim HJ; IPF-PRO Registry investigators. Predictors of death or lung transplant after a diagnosis of idiopathic pulmonary fibrosis: insights from the IPF-PRO Registry. Respir Res. 2019 May 30;20(1):105. doi: 10.1186/s12931-019-1043-9.
O'Brien EC, Durheim MT, Gamerman V, Garfinkel S, Anstrom KJ, Palmer SM, Conoscenti CS. Rationale for and design of the Idiopathic Pulmonary Fibrosis-PRospective Outcomes (IPF-PRO) registry. BMJ Open Respir Res. 2016 Jan 11;3(1):e000108. doi: 10.1136/bmjresp-2015-000108. eCollection 2016.
Other Identifiers
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1199.174
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00046131
Identifier Type: -
Identifier Source: org_study_id
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