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Idiopathic Pulmonary FibrosisPhase 3TETON-OLENCT04905693

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

A Phase 3 study testing Inhaled Treprostinil and Treprostinil Ultrasonic Nebulizer in people with Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by United Therapeutics at 192 sites in 18 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Inhaled Treprostinil and Treprostinil Ultrasonic Nebulizer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,850 participants
Where
192 sitesin 18 countries
Study dates
6 Sep 2022to Dec 2029
Phase
Phase 3

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 40 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.
  • The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
  • Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
  • 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.
  • In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
  • 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). Subjects participating in non-interventional, observational, or registry studies are eligible.

Trial locations and contacts

192 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

192 sites in 18 countries

United States81 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87106

  • University of Michigan Int Med Pulmonary and critical care

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare Atlanta

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22903

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45227

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Prisma Health Midlands

    Columbia, South Carolina, 29203

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201

  • Stony Brook Advanced Specialty Care

    Commack, New York, 11725

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8550

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Clinical Trials Center of Middle Tennessee

    Franklin, Arizona, 37067

  • University of Florida Health at Shands

    Gainesville, Florida, 32610

  • PulmonIx, LLC

    Greensboro, North Carolina, 27403

  • East Carolina University

    Greenville, North Carolina, 27834

  • Penn State Milton S.Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Pulmonary Disease Specialists, PA d/b/a PDS Research

    Kissimmee, Florida, 34741

  • StatCare Pulmonary Consultants, PLLC

    Knoxville, Tennessee, 37919

  • UC San Diego Health

    La Jolla, California, 92037

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

  • University of Louisville Healthcare Outpatient Center

    Louisville, Kentucky, 40202

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • A & A Research Consultants, LLC

    McAllen, Texas, 78503

  • Metroplex Pulmonary and Sleep Center PA

    McKinney, Texas, 75069

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Intermountain Healthcare

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

  • Northwell Health

    New Hyde Park, New York, 11042

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Weill Cornell Medical Center

    New York, New York, 10021

  • NewportNativeMD, Inc

    Newport Beach, California, 92663

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Creighton University Clinical Research Office

    Omaha, Nebraska, 68124

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson,Hospital University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Banner University Medical Center-Phoenix

    Phoenix, Arizona, 85006

  • St. Joseph's Hospital and Medical Center - Norton Thoracic Institute

    Phoenix, Arizona, 85013

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230

  • Mayo Clinic, Division of Pulmonary and Critical Care Medicine

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Corewell Health William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Health Medical Center

    Sacramento, California, 95817

  • University of Utah Health

    Salt Lake City, Utah, 84108

  • University of California San Francisco

    San Francisco, California, 94143

  • LSU Health Science Center Shreveport

    Shreveport, Louisiana, 71103

  • Adventist Healthcare White Oak Medical Center

    Silver Spring, Maryland, 98374

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305

  • University of South Florida Health

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • University of Arizona

    Tucson, Arizona, 85724

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain13 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Clinico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

France12 sites

  • CHU Amiens-Picardie

    Amiens, 80054

  • AP-HP - Hopital Avicenne

    Bobigny, 93000

  • Hospices Civils De Lyon - Université Hospital of Lyon

    Bron, 69500

  • CHU Caen Normandie

    Caen, Calvados, 14000

  • Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille

    Marseille, Bouches-du-Rhône, 13015

  • AP-HP - Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôptial Bichat

    Paris, 75018

  • Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche

    Reims, 51092

  • Hôpital Pontchaillou

    Rennes, 35000

  • CHU Rouen Hopital Charles Nicolle

    Rouen, Seine-Maritime, 76000

  • Hopital Larrey

    Toulouse, Haute-Garonne, 31059

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044

Other trials in France

Israel10 sites

  • Barzilai Medical Center

    Ashkelon, Southern District, 78278

  • Hillel Yaffe Medical Center

    Hadera, Haifa District, 38100

  • Lady Davis Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428100

  • Rabin Medical Center - PPDS

    Petah Tikva, 49100

  • Sheba Medical Center - PPDS

    Ramat Gan, Tel Aviv, 52621

  • Kaplan Medical Center

    Rehovot, Central District, 76100

  • Tel Aviv Sourasky Medical Center - PPDS

    Tel Aviv, 64239

Other trials in Israel

Argentina9 sites

  • Centro Médico Dra. De Salvo

    Buenos Aires, C1426ABP

  • CINME S.A. - Centro de Investigaciones Metabólicas

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP

  • Sanatorio Allende Cerro

    Córdoba, Córdoba Province, 5021

  • Instituto Ave Pulmo - Fundación enfisema

    Mar del Plata, Buenos Aires, 7600

  • Centro Médico INSARES

    Mendoza, Mendoza Province, 5500

  • Instituto Medico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

  • Sanatorio Parque de Rosario - Consultorios Externos

    Rosario, Santa Fe Province, 2000

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigaciones en Patologías Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Australia9 sites

  • Cairns Hospital

    Cairns, Queensland, 5870

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Lung Research Qld

    Chermside, Queensland, 4032

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Macquarie University

    Macquarie Park, New South Wales, 2109

  • Alfred Health

    Melbourne, Victoria, 3004

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium8 sites

  • vzw AZORG - Aalst - Moorselbaan

    Aalst, 9300

  • Hôpital Erasme

    Anderlecht, Brussels Capital, 1070

  • Ziekenhuis Aan de Stroom

    Antwerp, 2020

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

  • CHR de la Citadelle

    Liège, 4000

  • CHU de Liège

    Liège, 4000

  • CHU UCL Namur - Site Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Italy8 sites

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126

  • A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"

    Catania, Sicily, 95123

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, 47121

  • Gruppo MultiMedica SpA - Ospedale San Giuseppe

    Milan, Lombardy, 20123

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna, 41124

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Rome, Lazio, 00168

  • Azienda ospedaliero-universitaria Senese

    Siena, Tuscany, 53100

Other trials in Italy

South Korea7 sites

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggido, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

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

    Seoul, Seoul Teugbyeolsi, 03312

  • SMG - SNU Boramae Medical Center

    Seoul, Seoul Teugbyeolsi, 07061

  • Korea University Anam Hospital

    Seoul, 02841

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Canada6 sites

  • Dynamic Drug Advancement Limited

    Ajax, Ontario, L1S2J5

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Centre d'investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T7A1

  • St.Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Germany6 sites

  • Zentralklinik Bad Berka GmbH Klinik für Pneumologie

    Bad Berka, Thuringia, 99437

  • Prüfstelle der GWT am Fachkrankenhaus Coswig

    Coswig, Saxony, 1640

  • Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, North Rhine-Westphalia, 45239

  • SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin

    Löwenstein, Baden-Wurttemberg, 74245

  • LMU Klinikum der Universität München

    München, Bavaria, 81377

  • RoMed Klinikum Rosenheim

    Rosenheim, Bavaria, 83022

Other trials in Germany

Chile5 sites

  • Centro Respiratorio Integral Limitada

    Quillota, Valparaiso, 2260000

  • Instituto Nacional del tórax

    Santiago, Santiago Metropolitan, 7500691

  • Fundación Médica San Cristobal

    Santiago, Santiago Metropolitan, 76302266

  • CEC Centro de Estudios Clínicos

    Santiago, Santiago Metropolitan, 7750495

  • Centro de Investigación del Maule SpA

    Talca, Maule Region, 3481349

Other trials in Chile

Taiwan5 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • E-DA hospital

    Kaohsiung City, 82445

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Far Eastern Memorial Hospital

    New Taipei City, 22060

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Denmark3 sites

  • Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit

    Aarhus N, 8200

  • Gentofte Hospital - Lungemedicinsk forskningsafdeling

    Hellerup, 2900

  • Odense University Hospital - Department of Respiratory Medicine

    Odense C, 5000

Other trials in Denmark

Mexico3 sites

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

    Mexico City, 14080

  • Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)

    Monterrey, Nuevo León, 64460

  • Unidad de Investigación Clínica en Medicina, S.C.

    Monterrey, Nuevo León, 64718

Other trials in Mexico

Peru3 sites

  • Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco

    Cusco, 08002

  • Clinica Ricardo Palma

    Lima, 15036

  • Hospital Central de la Fuerza Aérea del Perú

    Lima, 15046

Other trials in Peru

Netherlands2 sites

  • Zuyderland Medisch Centrum - Heerlen

    Heerlen, Limburg, 6419 PC

  • Erasmus MC -Dr. Molewaterplein 40

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

New Zealand2 sites

  • Canterbury Respiratory Research Group

    Christchurch, 8013

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

About this study

Official title: An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Read the detailed description

Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF or PPF, or the study is discontinued by the Sponsor (whichever is sooner).

Efficacy assessments will include spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]), time to clinical worsening, time to first acute exacerbation of IPF or 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 diffusion capacity of lungs for carbon monoxide (DLCO). Safety assessments will include monitoring for the development of AEs/SAEs, vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. In addition, up to 24 eligible subjects with IPF rolling over from Study RIN-PF-301 and up to 24 eligible subjects with PPF rolling over from Study RIN-PF-305 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Being tested
Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Keywords
Treprostinil, IPF, ILD, PPF
Medical subject headings
Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial

What participants receive

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

  • 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 NCT04905693
Study groupRoleWhat they receive
Inhaled TreprostinilExperimentalTreprostinil 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 to a target of 15 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. Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF

    Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs

    Measured: Baseline to 6 years

Timeline

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

  1. First posted28 May 2021
  2. Study start6 Sep 2022
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (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
Not applicable
Intervention model
Single group
Model description
Open-label Extension
Masking
None (open label)
Enrolment
1,850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905693
Sponsor's protocol ID
RIN-PF-302
Acronym
TETON-OLE
Status last verified
Oct 2026
First submitted
20 May 2021
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

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