- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01915511
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry (IPF/ILD-PRO)
November 24, 2023 updated by: Duke University
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (IPF-PRO/ILD-PRO) Registry
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data.
Blood samples will be collected periodically throughout the study for use in future research efforts.
For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
2000
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
- Name: Rosalia Blanco
- Phone Number: 919-660-0890
- Email: rosalia.blanco@duke.edu
Study Locations
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-
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Ponce, Puerto Rico, 00716
- Completed
- Ponce Research Institute
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama - Birmingham
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Contact:
- Brittany Harrison
- Phone Number: 205-934-4440
- Email: bnrouse@uabmc.edu
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Principal Investigator:
- Tracy Luckhardt, MD
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Arizona
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Phoenix, Arizona, United States, 85013
- Recruiting
- St. Joseph's Hospital
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Principal Investigator:
- Rajat Walia, MD
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Contact:
- Noor Elkurwi
- Phone Number: 602-406-1151
- Email: noor.elkurwi@commonspirit.org
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California
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Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California
-
Contact:
- Lynn Fukusima
- Email: Lynn.Fukushima@med.usc.edu
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Principal Investigator:
- Toby Maher, MD
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Los Angeles, California, United States, 90024
- Recruiting
- University of California - Los Angeles
-
Contact:
- Jennifer Perez
- Phone Number: 310-825-5800
- Email: JSPerez@mednet.ucla.edu
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Principal Investigator:
- John Belperio, MD
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Sacramento, California, United States, 95817
- Recruiting
- University of California, Davis
-
Principal Investigator:
- Namita Sood, MD
-
Contact:
- Paul Yegorov
- Email: pryegorov@ucdavis.edu
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Stanford, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Jeanette Estrada
- Phone Number: 831-600-6625
- Email: janestr@stanford.edu
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Principal Investigator:
- Rishi Raj, MD
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Recruiting
- Yale University
-
Contact:
- Sara Jean Turcotte-Foster
- Email: sarajean.turcotte-foster@yale.edu
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Principal Investigator:
- Mridu Gulati, MD
-
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Florida
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South Miami, Florida, United States, 33143
- Completed
- South Miami Hospital
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Tampa, Florida, United States, 33606
- Recruiting
- University of South Florida
-
Contact:
- Stephanie Lainez
- Phone Number: 813-660-6955
- Email: slainez@tgh.org
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Principal Investigator:
- Debabrata Bandyopadhyay, MD
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University
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Contact:
- Tracy Halabi
- Phone Number: 404-712-7458
- Email: tracy.halaby@emory.edu
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Principal Investigator:
- Srihari Veeraraghavan, MD
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Austell, Georgia, United States, 30106
- Recruiting
- Piedmont Healthcare
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Principal Investigator:
- Amy Case, MD
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Contact:
- Halle Sovich
- Phone Number: 404-561-1556
- Email: Halle.Sovich@piedmont.org
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
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Contact:
- Spring Holland
- Phone Number: 773-834-4053
- Email: sholland@bsd.uchicago.edu
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Principal Investigator:
- Mary Strek, MD
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Evanston, Illinois, United States, 60611
- Recruiting
- Northwestern University
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Contact:
- Phillip Cooper
- Phone Number: 312-503-0406
- Email: p-cooper@northwestern.edu
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Principal Investigator:
- Jane Dematte, MD
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Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Health System
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Contact:
- Adriana Martinez
- Email: amartinez59@luc.edu
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Principal Investigator:
- Daniel Dilling, MD
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas
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Contact:
- Elizabeth Dillon
- Phone Number: 913-588-4424
- Email: edillon2@kumc.edu
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Principal Investigator:
- Mark Hamblin, MD
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Kentucky
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Louisville, Kentucky, United States, 40202
- Completed
- University of Louisville
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University
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Principal Investigator:
- Joe Lasky, MD
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Contact:
- Sandy Ditta
- Phone Number: 504-988-4040
- Email: sditta@tulane.edu
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University from Virginia
-
Contact:
- Yousef Althulth
- Email: KPQ5SK@hscmail.mcc.virginia.edu
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Principal Investigator:
- Tessy Paul, MD
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Massachusetts
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Burlington, Massachusetts, United States, 01803
- Recruiting
- Lahey Clinic
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Contact:
- Yuxiu Lei
- Phone Number: 781-744-2940
- Email: Yuxiu.Lei@Lahey.org
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Principal Investigator:
- Timothy Liesching, MD
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Candace Flaherty
- Phone Number: 734-936-8301
- Email: cflah@med.umich.edu
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Principal Investigator:
- Kevin Flaherty, MD
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Mandi DeGrote
- Phone Number: 612-626-7609
- Email: carl1032@umn.edu
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Principal Investigator:
- Hyum Kim, MD
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University
-
Contact:
- Hannah Perkins
- Phone Number: 314-362-9919
- Email: hperkins@wustl.edu
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Principal Investigator:
- Tonya Russell, MD
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New York
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Albany, New York, United States, 12208
- Completed
- Albany Medical Center
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New York, New York, United States, 10016
- Recruiting
- NYU Medical Center
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Contact:
- Sasha Basdeo
- Email: Sasha.Basdeo@nyulangone.org
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Principal Investigator:
- Rany Condos, MD
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New York, New York, United States, 10065
- Recruiting
- Weill Medical College of Cornell University
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Principal Investigator:
- Robert Kaner, MD
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Contact:
- Jose Romero
- Phone Number: 646-962-2740
- Email: jlr4002@med.cornell.edu
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Recruiting
- UNC Chapel Hill
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Contact:
- Caleb Hemphill
- Phone Number: 984-974-2963
- Email: caleb_hemphill@med.unc.edu
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Principal Investigator:
- Jason Lobo, MD
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Durham, North Carolina, United States, 27705
- Recruiting
- Duke University
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Contact:
- Lisa Holmes
- Phone Number: 919-684-8726
- Email: lisa1.holmes@duke.edu
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Principal Investigator:
- Lake Morrison, MD
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Greensboro, North Carolina, United States, 27403
- Recruiting
- Pulmonix LLC
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Principal Investigator:
- Murali Ramaswamy, MD
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Contact:
- Schae Scott
- Email: schae.scott@pulmonix.com
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Wilmington, North Carolina, United States, 28401
- Recruiting
- PMG Research
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Contact:
- Lindsey Dawson
- Email: Lindsey.Dawson@accellacare.com
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Principal Investigator:
- Doug Lee, MD
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Health
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Contact:
- Bob Hmieleski
- Phone Number: 336-713-8550
- Email: bhmieles@wakehealth.edu
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Principal Investigator:
- Andrew Namen, MD
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Salem Chest &Southeastern Clinical Research Center
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Contact:
- Karen McCutcheon
- Phone Number: 336-659-8414
- Email: kmccutcheon@southeasternresearchcenter.com
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Principal Investigator:
- Reginal Fowler, MD
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Ohio
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Cincinnati, Ohio, United States, 45267
- Recruiting
- University of Cincinnati Medical Center
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Contact:
- Emillie Hoh
- Phone Number: 513-475-8400
- Email: hohek@ucmail.uc.edu
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Principal Investigator:
- Nishant Gupta
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
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Contact:
- Susan Gole
- Phone Number: 216-445-5836
- Email: GOLES@ccf.org
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Principal Investigator:
- Briam Southern, MD
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma
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Contact:
- Maria Mason
- Phone Number: 405-271-6173
- Email: maria-l-mason@ouhsc.edu
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Principal Investigator:
- Jad Kebbe, MD
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Oregon
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Portland, Oregon, United States, 97220
- Recruiting
- Oregon Clinic
-
Principal Investigator:
- David Hotchkin, MD
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Contact:
- Meg Day
- Phone Number: 503-963-3182
- Email: mday@orclinic.com
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Contact:
- Apurva Raje
- Phone Number: 240-472-1153
- Email: Apurva.Raje@Pennmedicine.upenn.edu
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Principal Investigator:
- Mary Porteous, MD
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Philadelphia, Pennsylvania, United States, 19144
- Recruiting
- Thomas Jefferson University
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Principal Investigator:
- Jesse Roman, MD
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Contact:
- Ramya Talluri, BSN, RN
- Email: RamyaPriya.Talluri@jefferson.edu
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Philadelphia, Pennsylvania, United States, 19140
- Completed
- Temple University
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South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
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Principal Investigator:
- Timothy Whelan, MD
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Contact:
- Audra Wiser
- Email: wisera@musc.edu
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Tennessee
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Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University
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Contact:
- James Del Greco
- Phone Number: 615-343-7068
- Email: james.del.greco@vumc.org
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Principal Investigator:
- Lisa Lancaster, MD
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Texas
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Dallas, Texas, United States, 75235
- Recruiting
- University of Texas Southwestern
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Contact:
- Reagan Volzer
- Email: Reagan.Volzer@UTSouthwestern.edu
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Principal Investigator:
- John Fitzgerald, MD
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Dallas, Texas, United States, 75246
- Recruiting
- Baylor University Medical Center at Dallas
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Principal Investigator:
- Yolanda Mageto, MD
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Contact:
- Eva Patel
- Phone Number: 214-820-5829
- Email: Eva.Patel@BSWHealth.org
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Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
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Principal Investigator:
- Ivan Rosas, MD
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Contact:
- Valeria Ortega
- Email: Valeria.OrtegaApraez@bcm.edu
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Houston, Texas, United States, 77030
- Recruiting
- Houston Methodist Lung Center
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Contact:
- Jennifer Lee
- Phone Number: 713-363-7537
- Email: jllee@houstonmethodist.org
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Principal Investigator:
- Zeenat Safdar, MD
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The Woodlands, Texas, United States, 77380
- Completed
- Renovatio Clinical
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Vermont
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Burlington, Vermont, United States, 05401
- Recruiting
- Vermont Lung Center
-
Contact:
- Anna Raymond
- Phone Number: 802-656-8307
- Email: anna.raymond@uvmhealth.org
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Principal Investigator:
- Marta Kokoszynska, MD
-
-
Virginia
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Lynchburg, Virginia, United States, 24501
- Recruiting
- Lynchburg Pulmonary Associates
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Principal Investigator:
- Albert Baker, MD
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Contact:
- Terry Palazzi
- Phone Number: 434-947-3963
- Email: tpalazzi@lynchburgpulmonary.com
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-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- The Medical College of Wisconsin
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Principal Investigator:
- Randolph Lipchik, MD
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Contact:
- Kiley Timler
- Phone Number: 414-955-6875
- Email: ktimler@mcw.edu
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-
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 of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
- Age 30 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
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 a clinical trial at the time of 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
|
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)
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
Collaborators
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
- 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.
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, 2028
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)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
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.
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