AzTrials
AzTrials

Progressive Pulmonary FibrosisPhase 3NCT05943535

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

A Phase 3 study testing Inhaled Treprostinil and Treprostinil Ultrasonic Nebulizer in people with Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by United Therapeutics at 165 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inhaled Treprostinil and Treprostinil Ultrasonic Nebulizer
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
698 participants
Where
165 sitesin 15 countries
Study dates
30 Oct 2023to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject gives voluntary informed consent to participate in the study.
  • Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
  • Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
  • Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:
  • Clinically significant decline in % predicted FVC based on ≥10% relative decline
  • Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms
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  • Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with increasing extent of fibrotic changes on chest imaging
  • Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
  • FVC ≥45% predicted at Screening (confirmed by central review).
  • Subjects must be on 1 of the following:
  • On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
  • Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.
  • Concomitant use of both nintedanib and pirfenidone is not permitted.
  • Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.
  • Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:
  • Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
  • Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
  • Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.
  • Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
  • Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
  • In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Who cannot join

  • Subject is pregnant or lactating.
  • Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC <0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
  • Subject has a diagnosis of IPF.
  • Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  • Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments.
  • Subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
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  • Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
  • Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
  • Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
  • Acute pulmonary embolism within 90 days prior to Baseline.
  • In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
  • In the opinion of the Investigator, life expectancy <12 months due to ILD or a concomitant illness.
  • Subject has received nerandomilast within 60 days prior to Baseline.

Trial locations and contacts

165 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

United Therapeutics Global Medical Information contact

919-485-8350

clinicaltrials@unither.com

165 sites in 15 countries

United States74 sites, 74 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Frederick Gentry, 505-272-1160, fgentry@salud.unm.edu

    Nour Assad, MD

    Recruiting

  • The Emory Clinic

    Atlanta, Georgia, 45227

    Mitzi Near, 404-712-9603, mnear@emory.edu

    Srihari Veeraraghavan, MD

    Recruiting

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

    Sarah Collins, 410-550-2062, shirsh1@jhmi.edu

    Mathew Lammi, MD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 45227

    Maura Deeley, 410-328-4535, madeeley@som.umaryland.edu

    Sarah R Williams

    Recruiting

  • UAB Lung Health Center

    Birmingham, Alabama, 35233

    Melessia Wells, 205-975-9332, mrasheed@uabmc.edu

    Tejaswini Kulkarni, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Mary Hays, 617-636-1334, Mary.M.Hays@tuftsmedicine.org

    Nicholas Hill, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Layla Rahimi, 617-724-5548, layla.rahimi@mgh.harvard.edu

    Leo C Ginns, MD

    Recruiting

  • Medical University of South Carolina-Nexus

    Charleston, South Carolina, 29425

    Angela Francisco, 843-792-3710, millare@musc.edu

    Rachana Krishna, MD

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    Yousef Althulth, 434-924-0749, KPQ5SK@hscmail.mcc.virginia.edu

    Hannah C Mannem, MD

    Recruiting

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

    Anna Shipp, 314-682-3653, Anna.Shipp@stlukes-stl.com

    Neil Ettinger, MD

    Recruiting

  • Northwestern Memorial Hospital, Clinical Research Unit

    Chicago, Illinois, 60611

    Aaron Gundersheimer, 312-503-7475, aaron.gundersheimer@northwestern.edu

    Bradford Bemiss, MD

    Recruiting

  • Rush University Medical Center Outpatient Pulmonary Clinic

    Chicago, Illinois, 60612

    Kimberly Saulsberry, 312-996-6275, Kimberly_P_Saulsberry@rush.edu

    Mark Yoder, MD

    Recruiting

  • UI Health Hospital

    Chicago, Illinois, 60612

    Hannah Carlson, hrc@uic.edu

    Dustin Fraidenburg, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Emillie Hoh, 513-584-1999, hohek@ucmail.uc.edu

    Nishant Gupta, MD

    Recruiting

  • St. Luke's Univeristy Health Network-Pulmonary & Critical Care

    Cincinnati, Ohio, 45227

    Jena Hagerty, 484-526-3890, Jena.hagerty@sluhn.org

    Douglas Corwin, MD

    Recruiting

  • Prisma Health Pulmonology-Richland

    Columbia, South Carolina, 29203

    Keera McKenna, 803-434-8262, keera.mckenna2@prismahealth.org

    Abhinav Gupta, MD

    Recruiting

  • The Ohio State University Wexner Medical CEnter

    Columbus, Ohio, 43201

    Benjamin Hood, 614-293-3351, benjamin.hood2@osumc.edu

    Nitin Bhatt, MD

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Brianna Kamran, 214-820-1685, brianna.kamran@bswhealth.org

    Yosafe Wakwaya, MD

    Recruiting

  • UT Southwestern Medical Center-Advanced Lung Clinic

    Dallas, Texas, 75390

    Maria Goralski, 214-645-2340, maria.goralski@utsouthwestern.edu

    Margaret Kypreos, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Lisa Holmes, 919-684-8726, lisa1.holmes@duke.edu

    Lake Morrison, MD

    Recruiting

  • Christopher King, MD

    Falls Church, Virginia, 22042

    Priscila Dauphin, 703-776-7128, priscila.dauphin@inova.org

    Christopher King, MD

    Recruiting

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067

    Lindsey Robbs, 615-205-8350, lrobbs@ctcmidtn.com

    Aaron Milstone, MD

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth

    Grand Rapids, Michigan, 49503

    Kendra Selby, 616-488-0281, kendra.selby@helendevoschildrens.org

    Pranav Kidambi, MD

    Recruiting

  • PulmonIx LLC

    Greensboro, North Carolina, 27403

    Lauren Hinshaw, 336-522-8870, lauren.hinshaw@pulmonix.com

    Murali Ramaswamy, MD

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Shravya Dharambhat, 252-744-1116, dharambhats22@ecu.edu

    Veeranna Maddipati, MD

    Recruiting

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi, 39501

    Bobby W Tullos, MD

    Recruiting

  • Pennsylvania State Hershey Medical Center and College of Medicine

    Hershey, Pennsylvania, 17033

    Timothy Sheehan, 717-531-0003, tsheehan@pennstatehealth.psu.edu

    Rebecca Bascom, MD

    Recruiting

  • Houston Methodist Outpatient Center

    Houston, Texas, 77030

    Nelson Villasmil Hernandez, 832-970-3187, navillasmilhernandez@houstonmethodist.org

    Sandeep Sahay, MD

    Recruiting

  • The University of Texas Health Science Center at Houston, McGovern Medical School

    Houston, Texas, 77030

    Mary Rangel, 713-500-6851, mary.rangel@uth.tmc.edu

    Rodeo Abrencillo, MD

    Recruiting

  • Ascension Medical Group St. Vincent's Lung Institute

    Jacksonville, Florida, 32204

    Jennifer McWilliams, 904-308-5764, jennifer.mcwilliams@ascension.org

    Akram Shibani, MD

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Inna Dawson, 904-953-3855, dawson.inna@mayo.edu

    Augustine S Lee, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Kimberly Lovell, 913-588-6067, klovell@kumc.edu

    Sahil Pandya, MD

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Rosann Gans, 816-304-1561, rgans@saint-lukes.org

    Mark Yagan, MD

    Recruiting

  • StatCare Pulmonary Consultants, PLLC

    Knoxville, Tennessee, 37919

    Tabitha McCauley, 865-934-2672, tabitha.mccauley@biomed-research.com

    Eric Weaver, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 45227

    Srushan Shankara bhaktula, 859-562-0882, ssh486@uky.edu

    Parijat Sen, MD

    Recruiting

  • Peter Morton Medical Building

    Los Angeles, California, 90095

    Jennifer Perez, 310-825-5800, jsperez@mednet.ucla.edu

    Stephen S Weigt, MD

    Recruiting

  • University of Louisville Healthcare Outpatient Research Clinic

    Louisville, Kentucky, 40202

    Belica Graf, 502-852-3184, belica.graf@louisville.edu

    Mohamed A Saad, MD

    Recruiting

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792

    Maggie Chilsen, 608-263-2704, mchilsen@clinicaltrials.wisc.edu

    Stephen J Halliday, MD

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Adriana Martinez, 708-216-2057, amartinez59@luc.edu

    Daniel Dilling, MD

    Recruiting

  • A & A Research Consultants, LLC

    McAllen, Texas, 78503

    Jaedan Chapa, 972-802-1512, jaedanchapa@hotmail.com

    Alfredo Renzo Arauco Brown, MD

    Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

    Ambreen Ahmed, 972-838-1892, aahmed@mpsleepcenter.com

    Shahrukh Kureishy, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-1222

    Kiley Timler, 414-955-6875, ktimler@mcw.edu

    Mark Barash, MD

    Recruiting

  • University of Minnesota Health Clinical Research Unit (CRU)

    Minneapolis, Minnesota, 55455

    Amanda DeGrote, carl1032@umn.edu

    Hyun Kim, MD

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Danielle Nasson, 831-507-4629, dani.memmott@imail.org

    Peter Crossno, MD

    Recruiting

  • The Vanderbilt Lung Institute

    Nashville, Tennessee, 37204

    Phyllis Young, 615-322-0368, phyllis.d.young@vumc.org

    Justin Hewlett, MD

    Recruiting

  • Northwell Health

    New Hyde Park, New York, 11042

    Sara Khan, 516-465-5437, skhan109@northwell.edu

    Arunabh Talwar, MD

    Recruiting

  • Tulane Medical Center

    New Orleans, Louisiana, 45227

    Sandy Ditta, 504-988-4040, sditta@tulane.edu

    Shigeki Saito, MD

    Recruiting

  • Weill Cornell Medicine, New York-Presbyterian Hospital

    New York, New York, 10065

    Christine Wu, 646-962-2833, chw4019@med.cornell.edu

    Anna Podolanczuk, MD

    Recruiting

  • NewportNativeMD, Inc.

    Newport Beach, California, 92663

    Grace Harvey, 949-791-8599 ext. 107, grace@newportnativemd.com

    Ryan Klein, MD

    Recruiting

  • Infinity Medical Center

    North Dartmouth, Massachusetts, 02747

    Cheryl O'Neil, 508-998-3041, coneil@infinitymedicalresearch.com

    Curtis J Mello, MD

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Jordan Perkins, 714-456-6875, jperkin3@hs.uci.edu

    Bassam Yaghmour, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sarah Alam, 609-668-7771, sarah.alam@pennmedicine.upenn.edu

    Michaela Anderson, MD

    Recruiting

  • Jefferson Honickman Center

    Philadelphia, Pennsylvania, 19107

    Ramya priya Talluri, 215-955-9792, ramyapriya.talluri@jefferson.edu

    Valeria Santibanez, MD

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Kim Selwood, 215-707-1359, kim.selwood@tuhs.temple.edu

    Rali Parth, MD

    Recruiting

  • Banner University Medical Center Phoenix Lung Institute

    Phoenix, Arizona, 85006

    Surya Olguin, 602-521-3300, suryaolguin@arizona.edu

    Sally Suliman, MD

    Recruiting

  • Norton Thoracic Institute

    Phoenix, Arizona, 85013

    Gabrielle Ambrose, 602-406-3825, gabrielle.ambrose@commonspirit.org

    Rajat Walia, MD

    Recruiting

  • Paradigm Clinical Research

    Redding, California, 45227

    Mandy Swanson, 530-247-7049, mswanson@paradigm-research.com

    Rafael Lupercio, MD

    Recruiting

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230

    Betsy Daniel, 804-288-5947, bdaniel@paraccess.com

    Shilpa Johri, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Teng Moua, 507-284-5398, moua.teng@mayo.edu

    Teng Moua, MD

    Recruiting

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48073

    Beverly Mauer, 248-551-2581, beverly.maurer@corewellhealth.org

    Enrique Calvo-Ayala, MD

    Recruiting

  • UC Davis Health Medical Center

    Sacramento, California, 95817

    Sarah Natera, 916-734-1820, srnatera@ucdavis.edu

    Namita Sood, MD

    Recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84108

    Heather Hammerschmidt, 801-585-5194, heather.hammerschmidt@hsc.utah.edu

    Mary Scholand, MD

    Recruiting

  • Methodist Hospital

    San Antonio, Texas, 78229

    Susana Mondaca, 210-552-3255, susana.mondacabolanos@hcahealthcare.com

    Charles Burch, MD

    Recruiting

  • Paradigm Clinical Research

    San Diego, California, 92108

    Chery Bolovits, 858-274-4226, cbolovits@paradigm-research.com

    Daniel Jones, MD

    Recruiting

  • Adventist Healthcare White Oak Medical Center

    Silver Spring, Maryland, 20904

    Jennifer Hernandez, 240-637-5024, jhernandez1@adventisthealthcare.com

    Jonathan Cohen, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Megan Baldenweck, 314-362-3705, meganbaldenweck@wustl.edu

    Tonya D. Russell, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94305

    Jannet Estrada, janestr@stanford.edu

    Rishi Raj, MD

    Recruiting

  • Stony Brook Advanced Specialty Care

    Stony Brook, New York, 11794-8172

    Jacqueline Skarre, 631-444-9033, jacqueline.skarre@stonybrookmedicine.edu

    Alpa Desai, MD

    Recruiting

  • TGH/USF Center for Advanced Lung Disease and Lung Transplant

    Tampa, Florida, 33606

    Brenda Farlow, 813-844-3430, bfarlow@tgh.org

    Debabrata Bandyopadhyay, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Jane Wilson, 718-920-7916, jwilson4@montefiore.org

    Ali Mansour, MD

    Recruiting

  • Mercy Health St.Vincent Medical Center LLC

    Toledo, Ohio, 43608

    Joseph Bandi, 419-251-4919, jbandi@mercy.com

    Vinod Khatri, MD

    Recruiting

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Amen Hamed, 202-444-0895, amen.m.hamed@gunet.georgetown.edu

    Cristina Reichner, MD

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Osvaldo Perez, 954-659-5570, perezo4@ccf.org

    David Zisman, MD

    Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104

    Bob Hmieleski, 336-713-8555, bhmieles@wakehealth.edu

    Heather Clark

    Recruiting

Other trials in United States

Argentina9 sites, 9 recruiting

  • CINME Centro de Investigaciones Metabolicas

    Buenos Aires, C1056ABI

    Yesica Castillo, +541150319915, ycastillo@cinme.com.ar

    Maria Otaola, MD

    Recruiting

  • Fundación Respirar

    Buenos Aires, C1426ABP

    Antonela Iannazzo, +541170781548 ext ext. 702, iannazzoantonela@gmail.com

    María Cristina De Salvo, MD

    Recruiting

  • Instituto de Medicina Respiratoria

    Córdoba, 5003

    Angélica Baima, +543514888200, abaima@damic.com.ar

    Alexis Cazaux, MD

    Recruiting

  • Sanatorio Allende Cerro

    Córdoba, 5021

    Maria Gracia de la Vega, +54351269200, mgdelavega@sanatorioallende.com

    Viviana Alejandra Moyano

    Recruiting

  • Instituto Ave Pulmo - Fundacion enfisema

    Mar del Plata, Buenos Aires, 7600

    Mario Fernando Sabas, (223) 410-8383 ext. 82, fsabas@gmail.com

    Luis Arturo Wehbe, MD

    Recruiting

  • Instituto Medico Rio Cuarto

    Río Cuarto, Córdoba Province, 5800

    Sebastián Etchevers, +5491131077237, sebastianet@gmail.com

    Mauricio J Eceiza, MD

    Recruiting

  • Sanatorio Parque de Rosario - Consultorios Externos

    Rosario, Santa Fe Province, 2000

    Julieta Nasurdi, +543414200222, julinasurdi99@gmail.com

    Silvina Mannarino, MD

    Recruiting

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000

    Maria Jose Guzman, +543814212611, ipr_mariajose@yahoo.com.ar

    Ramon A Rojas, MD

    Recruiting

  • CIMER-Centro Integral de Medicina Respiratoria

    San Miguel de Tucumán, Tucumán Province

    Natalia Juarez Babiano, +543812577481, nataliajuarezbabiano1@gmail.com

    Altieri Hector, MD

    Recruiting

Other trials in Argentina

Australia9 sites, 9 recruiting

  • Eastern Health Box Hill Hospital

    Box Hill, Victoria, 3128

    Alan Young, 61390952415, alan.young@easternhealth.org.au

    Francis Thien, MD

    Recruiting

  • The Prince Charles Hospital

    Brisbane, Queensland, Australia

    Alan Carew, 61731394000, alan.carew@health.qld.gov.au

    John Andrew Mackintosh

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Alan Teoh, (02) 9515 4188, alan.teoh@health.nsw.gov.au

    Tamera Corte, Prof.

    Recruiting

  • Lung Research QLD

    Chermside, Queensland, 4032

    Sandra Bancroft, 61 7 3154 6376, sandy@lrq.com.au

    Daniel Chambers

    Recruiting

  • Monash Health-Monash Medical Centre

    Clayton, Victoria, 3168

    Yvonne Ng, 61395942900, yvonne.ng@monashhealth.org

    Xun Li, MD

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Yet Khor, 613412230524, yethong.khor@austing.org.au

    Nicole Soo Goh, MD

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, 2217

    Ajantha Raguparan, 6191132325, ajantha.raguparan@health.nsw.gov.au

    Alexandra Smith, MD

    Recruiting

  • Institute for Respiratory Health - Midland

    Midland, Western Australia, 6056

    Kaye McMullan, 61863173486, kaye.mcmullan@resphealth.uwa.edu.au

    David Manners, MD

    Recruiting

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

    Michelle Young, MD, 618 6151 0888, michelle.c.young@resphealth.uwa.edu.au

    Vidya Navaratnam, MD

    Recruiting

Other trials in Australia

Israel9 sites, 9 recruiting

  • Barzilai Medical Center

    Ashkelon, 7830604

    Mohamed Alamor, (972) 585-5111 x48, mohamedala@bmc.gov.il

    Ori Wand, MD

    Recruiting

  • Hillel Yaffe Medical Center

    Hadera, 3846201

    Marinella Beckerman, 97246304487, marinellab@hy.health.gov.il

    Michael Kuchuk, MD

    Recruiting

  • Rabin Medical Center

    Haifa, 3436212

    Michal Shteinberg, (972) 4-8250517, michalsh4@clalit.org.il

    Yochai Adir, Prof

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Ariel Rokach, +972-2-6555111, arielr@szmc.org.il

    Gabriel Izbicki, MD

    Recruiting

  • The Hadassah University Medical Center Ein Kerem Hospital

    Jerusalem, 9112001

    Rottem Kuint, +972-2-6776817, kuint@hadassah.org.il

    Neville Berkman, Prof.

    Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164

    Lilach Israeli-Shani, (972)-9-7471556, lilach.israeli@clalit.org.il

    David Shitrit, MD

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Maayan Flaschner, +972 545675938, maayanfl@clalit.org

    Osnat Livne-Shtraichman, MD

    Recruiting

  • Kaplan Medical Center

    Rehovot, 7551041

    Nina Azarov, (972) 8-9441829, nina.azarov@gmail.com

    Alexander Yarmolovsky, MD

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Irina Fomin, (972) 3-6973591, irenaf@tlvmc.gov.il

    Amir Bar-Shai, MD

    Recruiting

Other trials in Israel

Germany8 sites, 8 recruiting

  • Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin

    Bad Berka, 99437

    Veronika Gath, (439) 355016458, veronika.gath@zentralklinik.de

    Michael Weber, MD

    Recruiting

  • Prufstelle der GWT am Fachkrankenhaus Coswig

    Coswig, 01640

    Marcus Vogler, vogler@fachkrankenhaus-coswig.de

    Dirk Koschel, MD

    Recruiting

  • uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

    Eda Burcur Börner, (492) 014-334532, eda.boerner@rlk.uk-essen.de

    Francesco T Bonella, MD

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

    Ilona Olzik

    511 532-3692, olzik.ilona@mh-hannover.de

    Recruiting

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

    Katrin Schwedler, 4956735011577, k.schwedler@lungenfachklinik-immenhausen.de

    Peter Hammerl, Dr. med.

    Recruiting

  • SLK Kliniken Heilbronn GmbH

    Löwenstein, 74245

    Biljana Joves, (497)130 156611, biljana.joves@slk-kliniken.de

    Jonas Kuon, Dr

    Recruiting

  • LMU Klinikum Medizinische Klinik und Poliklinik V

    München, 81377

    Tobias Veit, (498)9440075310, tobias.veit@med.uni-muenchen.de

    Jurgen Behr, MD

    Recruiting

  • RoMed Klinikum Rosenheim-Ellmaierstr. 23

    Rosenheim, Bavaria, 83022

    Stefan Jungbauer, (498) 031-3657103, stefan.jungbauer2@ro-med.de

    Stephan Budweiser, MD

    Recruiting

Other trials in Germany

Belgium7 sites, 7 recruiting

  • AZORG

    Aalst, 9300

    Elke Hardeman, +32 53 72 42 89, elke.hardeman@AZORG.be

    Valerie Adam, MD

    Recruiting

  • ZAS Middelheim

    Antwerp, 2020

    Johan Clukers, +32 3 280 36 84, johan.clukers@zas.be

    Hans Slabbynck, MD

    Recruiting

  • CUB Hopital Erasmde

    Brussels, 1070

    Sebastien Van Laethem, +32 486 65 68 65, sebastien.vanlaethem@chu-charleroi.be

    Benjamin Bondue, MD

    Recruiting

  • Cliniques Universitaires St.-Luc

    Brussels, 1200

    Sophie Gohy, +32 2 764 80 84, sophie.gohy@uclouvain.be

    Antoine Froidure, MD

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Anja Delporte, 3293320228, anja.delporte@uzgent.be

    Geert Van Pottelberge, MD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Nico De Crem, +32 16 34 22 13, nico.decrem@uzleuven.be

    Wim Wuyts, MD

    Recruiting

  • CHU de Liège

    Liège, 4000

    Fanny Gester, +32 4 323 78 81, fanny.gester@chuliege.be

    Julien Guiot, MD

    Recruiting

Other trials in Belgium

Canada7 sites, 7 recruiting

  • Dynamic Drug Advancement Limited

    Ajax, Ontario, L1S 2J5

    Cynthia Lee, (647) 460-9594, crc2@dynamicdrugadvancement.com

    George Philteos, MD

    Recruiting

  • St.Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    Sarah Goodwin, (905) 521-6130, sgoodwin@stjoes.ca

    Nathan Hambly, MD

    Recruiting

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

    Danae Tassy, (514) 254-7455, danae.tassy.cemtl@ssss.gouv.qc.ca

    Ping Shi Zhu, MD

    Recruiting

  • CIC Mauricie inc.

    Québec, Quebec, G8T 7A1

    Mireille Devost, (819) 373-1128, mdevost@cic-mauricie.ca

    Émilie Millaire, MD

    Recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

    Veronica Marcoux, Dr.

    Recruiting

  • Diex Recherche Inc. - Division Sherbrooke Est

    Sherbrooke, Quebec, J1E 0N8

    Annie-Pier Beauchesne, 8193462887, apbeauchesne@diex.ca

    Christophe He, MD

    Recruiting

  • St.Paul's Hospital

    Vancouver, British Columbia, V6Z 176

    Jeff Wong, (604) 682-2344 ext. 63199, jwong145@providencehealth.bc.ca

    Christopher Ryerson, MD

    Recruiting

Other trials in Canada

Italy7 sites, 7 recruiting

  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Presidio Ospedaliero Gaspare Rodolico

    Catania, 95123

    Antonio Galia, 3909537814268, anto.galia95@gmail.com

    Carlo Vancheri

    Recruiting

  • Azienda Unita Sanitaria Locale Della Romagna Ospedale "Gian Battista Morgagni - Luigi Pierantoni" di Forlì

    Forlì, 47121

    Luca Donati, 390543735828, luca.donati@irst.emr.it

    Claudia Ravaglia, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena

    Modena, 41124

    Valentina Ruggieri, 3900594225762, valentina.ruggieri@unimore.it

    Stefania Cerri, MD

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza

    Gabriella Marsoni, 390392333962, gabriella.marsoni@irccs-sangerardo.it

    Fabrizio Luppi

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 168

    Diana Verdirosi, 390630157724, diana.verdirosi@policlinicogemelli.it

    Giacomo Sgalla

    Recruiting

  • Azienda Ospedaliero-Universitaria Senese

    Siena, 53100

    Benedetta Di Ruggiero, +39 0577586717, benedettadiruggiero@gmail.com

    Elena Bargagli, MD

    Recruiting

  • Centro Ricerche Cliniche di Verona SrL Pneumology Unit

    Verona, 37134

    Mirandola Giorgia, 390458126622, giorgia.mirandola@crc.vr.it

    Claudio Micheletto

    Recruiting

Other trials in Italy

Chile6 sites, 6 recruiting

  • Centro de Investigacion Curico

    Curicó, Maule Region, 3341643

    Reinaldo Eduardo Cortez de la Fuente, +56991591749, reinaldante@gmail.com

    Victor Antonio Martinez Hagen, MD

    Recruiting

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, Valparaiso, 2260000

    Leon Fernando Ovalle Jarpa, 56992356201, fdoovalle@hotmail.com

    Juana Rosa Pavie Gallegos, MD

    Recruiting

  • CEC Centro Estudios Clinicos

    Santiago, Santiago Metropolitan, 7550495

    Nicolas Cataldo, 56 965783567, ncataldocec@gmail.com

    Georgina Viviana Miranda Saez, MD

    Recruiting

  • Fundacion Medica San Cristobal

    Santiago, Santiago Metropolitan, 7630226

    Eliana Andahur Orellana, +56965132877, eandahuro@udd.cl

    Ricardo Luis Sepulveda Moncayo, MD

    Recruiting

  • Biocinetic Ltda.

    Santiago, Santiago Metropolitan, 8320000

    Beatriz Diaz, +56226965804, beatriz.diaz@cecim.cl

    Ricardo Alexis Fritz Garrido, MD

    Recruiting

  • Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)

    Viña del Mar, Valparaiso, 2520000

    Magdalena Reyes, +56 32 332 0863, magdalena.reyes@cieri.cl

    Felipe Eduardo Saavedra Gonzalez, MD

    Recruiting

Other trials in Chile

France6 sites, 6 recruiting

  • Hôpital Avicennes

    Bobigny, 93000

    Morgane Didier, 33 1 48 95 51 28, didier.morgane@aphp.fr

    Hilario Nunes, MD

    Recruiting

  • Hospices civils de Lyon - Hôpital Louis Pradel

    Bron, 69500

    François Lestelle, 33 4 27 85 77 00, francois.lestelle@chu-lyon.fr

    Vincent Cottin, MD

    Recruiting

  • CHU Caen Normandie

    Caen, 14000

    Aurélien Justet, 33 2 31 06 46 77, bergot-e@chu-caen.fr

    Emmanuel Bergot, MD

    Recruiting

  • Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille

    Marseille

    Benjamin Coiffard, 33 4 91 96 61 45, benjamin.coiffard@ap-hm.fr

    Martine Reynaud-Gaubert, MD

    Recruiting

  • Rouen University Hospital

    Rouen, 7600

    Hélène Morisse Pradier, 33 2 32 88 8247, helene.morisse@chu-rouen.fr

    Mathieu Salaun, MD

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, Tours Cedex 9

    Laurent Plantier, 33 2 47 47 98 34, l.plantier@chu-tours.fr

    Julie Mankikian, MD

    Recruiting

Other trials in France

Peru6 sites, 6 recruiting

  • Hospital Nacional Adolfo Guevara Velasco

    Cusco, 08002

    Rosa Alfaro Carrasco, +51 84 238749, rosaalfaro_7@hotmail.com

    Sandra Graciela Vargas Marquez, MD

    Recruiting

  • Clinica Internacional - Sede Lima

    Lima, 15001

    Eneyda Llerena Zegarra, +51996663828, eneyda40@hotmail.com

    Alfredo Guerreros Benavides, MD

    Recruiting

  • Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco

    Lima, 15023

    Alva Silvia, 511 3410579, silvia9098@yahoo.com

    Alejandro M Peña Villalobos, MD

    Recruiting

  • Clinica Ricardo Palma

    Lima, 15036

    Judith Armas, juditharmas@gmail.com

    Cesar Fernando Villaran Ferreyros, MD

    Recruiting

  • Hospital Central de la Fuerza Aerea del Peru

    Lima, 15046

    Franklin Gutierrez Torres, +51 35300 ext. 2765, franklingutor@gmail.com

    Maria Carmela Faverio Mannucci, MD

    Recruiting

  • Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia

    Lima, 15088

    Marjorie Gaviria Haxhuell, 5112729720, gmarjorie03@hotmail.com

    Carlos A Iberico Barrera, MD

    Recruiting

Other trials in Peru

United Kingdom6 sites, 6 recruiting

  • Birmingham Heartlands Hospital

    Birmingham

    Caroline Gallagher, 0044 (0)121 424 1685, caroline.gallagher@uhb.nhs.uk

    Christopher Huntley, MD

    Recruiting

  • Royal Papworth Hospital

    Cambridge, CB2 0AY

    Helen Parfrey, (441) 480-3648 x49, helen.parfrey@nhs.net

    Christine Fiddley, MD

    Recruiting

  • NHS Lothian, Royal INfirmary of Edingburgh

    Edinburgh, EH16 4SA

    Manjit Cartlidge, (0044)1312421191, manjit.cartlidge@nhs.scot

    Nikhil Hirani, MD

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    Alexandra Lawrence, 0044 020 7188 7188 ext51052, alexandra.lawrence8@nhs.net

    Katherine Myall, MD

    Recruiting

  • Manchester University NHS Foundation Trust, North Manchester General Hospital

    Manchester, M8 5RB

    Huda Badri, 0044-1617202122, huda.badri@pat.nhs.uk

    Zoe Borril, MD

    Recruiting

  • NHS Tayside, Perth Royal Infirmary

    Perth, PH1 1NX

    Moses Effiong, 0044-776587099, moses.effiong@nhs.scot

    Mark Spears, MD

    Recruiting

Other trials in United Kingdom

South Korea5 sites, 5 recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Huiyeong Hwang, 82-10-2833-6768, highjumpp@naver.com

    Sung Hwan Jeong, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    LeeNa Kim, 82-31-787-8539, lnkim4572@naver.com

    Jong Sun Park, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Mija Kim, 82-10-7235-3168, aakmcaapu001@kumc.or.kr

    Eun Joo Lee, MD

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Yebin Park, 82-10-7163-5439, yebin.p1014@gmail.com

    Jin Woo Song, MD

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 3312

    SunHwa Ryu, 82-10-9340-0685, rsh515@hanmail.net

    Sang Haak Lee, MD

    Recruiting

Other trials in South Korea

New Zealand3 sites, 3 recruiting

  • Aotearoa Clinical Trials Trust- Middlemore Hospital

    Auckland

    Jennifer Treacy, 64021610589, jennfier.treacy@aotearoatrials.nz

    Conor Odochartaigh, MD

    Recruiting

  • Canterbury Respiratory Research Group

    Christchurch, Canterbury, 8011

    Sara Pure, +64 3 364 1157, Sara.prue@cdhb.health.nz

    Michael Epton, MD

    Recruiting

  • Waikato Hospital

    Hamilton, 3204

    Sandra Hopping, 64 21 2407432, sandra.hopping@waikatodhb.co.nz

    Catherina Chang

    Recruiting

Other trials in New Zealand

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Hung Yuan-Chen, 886-7-3121101 ext. 7734, sealion12133@hotmail.com

    Sheu Chau-Chyun, MD

    Recruiting

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

    Yi-Chun Shih, 886 929-090-012, show650401@yahoo.com.tw

    Kuo-Tung Huang, MD

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Yi-Chun Shih, +886 929-090-012, show650401@yahoo.com.tw

    Pin-Kuei Fu, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Read the detailed description

Study RIN-PF-305 is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.

Efficacy assessments include spirometry (forced vital capacity [FVC]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.

Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.

Being tested
Placebo, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Keywords
Treprostinil, PPF, ILD
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo administered QID

  • Inhaled TreprostinilDrug

    Also called Tyvaso

    Inhaled treprostinil (6 mcg/breath) administered QID

  • Treprostinil Ultrasonic NebulizerDevice

    Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Study groups in NCT05943535
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo inhaled using an ultrasonic nebulizer QID
Receives: Drug: Placebo; Device: Treprostinil Ultrasonic Nebulizer
Inhaled TreprostinilExperimentalTreprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
Receives: Drug: Inhaled Treprostinil; Device: Treprostinil Ultrasonic Nebulizer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Absolute FVC from Baseline to Week 52

    The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.

    Measured: Baseline to Week 52

Secondary outcomes (6)

  1. Time to First Clinical Worsening

    Clinical worsening is monitored from randomization until 1 of the following criteria are met: death (all causes), hospitalization due to a respiratory indication, or ≥10% relative decline in % predicted FVC.

    Measured: Baseline to Week 52

  2. Time to First Acute Exacerbation of ILD

    An exacerbation of ILD is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality.

    Measured: Baseline to Week 52

  3. Overall Survival at Week 52

    Vital status will be assessed for all subjects at Week 52, including those who discontinue the study prematurely or who withdraw consent.

    Measured: Week 52

  4. Change in % Predicted FVC from Baseline to Week 52

    The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Percent predicted FVC is calculated based on factors such as race, sex, age, height, and weight.

    Measured: Baseline to Week 52

  5. Change in K-BILD Questionnaire Score from Baseline to Week 52

    The K-BILD is a self-administered, 15-item questionnaire validated for patients with ILD consisting of 3 domains (breathlessness and activities, psychological, and chest symptoms).

    Measured: Baseline to Week 52

  6. Change in DLCO from Baseline to Week 52

    The DLCO measurement measures how well oxygen moves from the lungs to the blood.

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start30 Oct 2023
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
698 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943535
Sponsor's protocol ID
RIN-PF-305
Status last verified
Jul 2026
First submitted
5 Jul 2023
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Nathan SD, Behr J, Cottin V, Lancaster L, Smith P, Deng CQ, Breytenbach N, Bell H, Peterson L, Flaherty KR. Study Design and Rationale for the TETON-PPF Phase 3, Randomized, Controlled Clinical Trial of Inhaled Treprostinil in the Treatment of Progressive Pulmonary Fibrosis. CHEST Pulm. 2024 Nov 19;3(2):100124. doi: 10.1016/j.chpulm.2024.100124. eCollection 2025 Jun.

    PubMed 42548323

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled Treprostinil and Treprostinil Ultrasonic Nebulizer in people with Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by United Therapeutics at 165 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Argentina, Australia, Israel, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact United Therapeutics Global Medical Information (919-485-8350, clinicaltrials@unither.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Absolute FVC from Baseline to Week 52 (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05943535, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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