Recruiting

Observational StudyIdiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Sponsor:

Duke University

Code:

NCT01915511

Conditions

Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Study ID

NCT01915511

Start date

Jun, 2014

Status verified date

Jul, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Data on natural history of IPF & non-IPF chronic fibrosing ILD [ Time Frame: 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) ]
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) ]
Blood samples for future research. [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Rosalia Blanco

919-660-0890 rosalia.blanco@duke.edu

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Arnissa Hopson

205-934-1657 agoggins@uabmc.edu

Principal Investigator:

Tejaswini Kulkarni, MD

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Daniel Castaneda-Beltran

602-827-2347 dcastanedabeltra@arizona.edu

Principal Investigator:

Sally A Suliman, MD

University of California - Los Angeles

Recruiting

Los Angeles, California, United States, 90024

Contacts

Stephanie Roblero

310-627-2319 sroblero@mednet.ucla.edu

Principal Investigator:

John Belperio, MD

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Lynn Fukusima

Lynn.Fukushima@med.usc.edu

Principal Investigator:

Toby Maher, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Summer Zhu

650-724-5424 szhuye@stanford.edu

Principal Investigator:

Rishi Raj, MD

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Olivia Brohl

303-724-0641 Olivia.brohl@cuanschutz.edu

Principal Investigator:

Joyce Lee, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Maksym Minasyan

203-785-4177 maksym.minasyan@yale.edu

Principal Investigator:

Mridu Gulati, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32610-3175

Contacts

Lisbetty Lugo

lisbetty.lugo@medicine.ufl.edu

Principal Investigator:

Diana Gomez Manjarres, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Abigail Eglinton

813-660-6955 ahughes@tgh.org

Principal Investigator:

Jose D Herazo-Maya, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Tracy Halabi

404-712-7458 tracy.halaby@emory.edu

Principal Investigator:

Srihari Veeraraghavan, MD

Piedmont Healthcare

Recruiting

Austell, Georgia, United States, 30106

Contacts

Munachi (Muna) Iwotor

404-291-9062 munachi.iwotor@piedmont.org

Principal Investigator:

Amy Case, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Vanita Patel

vpatel4@bsd.uchicago.edu

Principal Investigator:

Mary Strek, MD

Northwestern University

Recruiting

Evanston, Illinois, United States, 60611

Contacts

Phillip Cooper

312-503-0406 p-cooper@northwestern.edu

Principal Investigator:

Bradford Bemiss, MD

Loyola University Health System

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Sloan White

swhite29@luc.edu

Principal Investigator:

Daniel Dilling, MD

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Sandy Ditta

504-988-4040 sditta@tulane.edu

Principal Investigator:

Joe Lasky, MD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Deepti Naidu

313-916-8732 dnaidu1@HFHS.ORG

Principal Investigator:

Asif Abdul Hameed, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Mandi DeGrote

612-626-7609 carl1032@umn.edu

Principal Investigator:

Hyum Kim, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Leadeashia Brackett

601-496-7814 lbrackett@umc.edu

Principal Investigator:

Kimberly Dobbs, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Mona Noroozi

314-362-3705 mnoroozi@wustl.edu

Principal Investigator:

Tonya Russell, MD

Weill Medical College of Cornell University

Recruiting

New York, New York, United States, 10065

Contacts

Alicia Morris

646-692-2741 ajm2017@med.cornell.edu

Principal Investigator:

Kerri Aronson, MD

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jackson Pettee

Jackson_pettee@med.unc.edu

Principal Investigator:

Jason Lobo, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Lauren Gray

919-684-7317 lauren.gray@duke.edu

Principal Investigator:

Lake Morrison, MD

Pulmonix LLC

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Mei Zheng

336-522-8870 mei.zheng@pulmonix.com

Principal Investigator:

Murali Ramaswamy, MD

Wake Forest Baptist Health

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Bob Hmieleski

336-713-8550 bhmieles@wakehealth.edu

Principal Investigator:

Andrew Namen, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ron Wehrmann

2164450574 wehrmar@ccf.org

Principal Investigator:

Briam Southern, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Benjamin Hood

benjamin.hood2@osumc.edu

Principal Investigator:

John Odackal

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Maria Mason

405-271-6173 maria-l-mason@ouhsc.edu

Principal Investigator:

Jad Kebbe, MD

Oregon Clinic

Recruiting

Portland, Oregon, United States, 97220

Contacts

Meg Day

503-963-3182 mday@orclinic.com

Principal Investigator:

David Hotchkin, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Luis Cardenas-Osorio

215-707-3311 Luis.Cardenas-Osorio@tuhs.temple.edu

Principal Investigator:

Rachel Criner, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19144

Contacts

Ramya Talluri, BSN, RN

RamyaPriya.Talluri@jefferson.edu

Principal Investigator:

Ross Summer, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Audra Wiser

wisera@musc.edu

Principal Investigator:

Timothy Whelan, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

James Del Greco

615-343-7068 james.del.greco@vumc.org

Principal Investigator:

Justin Hewlett, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Maira Ortiz

214-645-1295 Maira.OrtizBerrio@UTSouthwestern.edu

Principal Investigator:

John Fitzgerald, MD

Baylor University Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75246

Contacts

Kristina Perez

817-922-2570 Kristina.Perez@BSWHealth.org

Principal Investigator:

Yolanda Mageto, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Maria C Perea

Maria.Perea@bcm.edu

Principal Investigator:

Ivan Rosas, MD

Houston Methodist Lung Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Laura Valecillos Loukidis

346-238-4637 lvvalecillosloukidis@houstonmethodist.org

Principal Investigator:

Zeenat Safdar, MD

The University of Texas Health Science Center At Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Beverly Rios

713-486-6152 Beverly.Rios@uth.tmc.edu

Principal Investigator:

Rodeo Abrencillo, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Adeline Langer

801-581-5811 adeline.langer@hsc.utah.edu

Principal Investigator:

Mary Beth Langer, MD

Inova

Recruiting

Falls Church, Virginia, United States, 22042-3307

Contacts

Taruni Maganti

703-776-3230 Taruni.Maganti@inova.org

Principal Investigator:

Jared Wilkinson, MD

More Information

Sponsor

Duke University

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Keywords

Idiopathic pulmonary fibrosis
Pulmonary fibrosis
IPF
Registry
1199.174
Interstitial Lung Disease
ILD
Interstitial Lung Disease with Progressive Phenotype

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-12.