Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)

May 21, 2026 updated by: United Therapeutics

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Centro Médico Dra. De Salvo
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
        • CINME S.A. - Centro de Investigaciones Metabólicas
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto Ave Pulmo - Fundacion Enfisema
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5021
        • Sanatorio Allende Cerro
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Instituto Médico Río Cuarto
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, 5500
        • Centro Médico INSARES
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Sanatorio Parque de Rosario - Consultorios Externos
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro Integral de Medicina Respiratoria (CIMER)
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigaciones en Patologias Respiratorias
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Cairns, Queensland, Australia, 5870
        • Cairns Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
      • Chermside, Queensland, Australia, 4032
        • Lung Research Qld
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health
  • Belgium
      • Aalst, Belgium, 9300
        • vzw AZORG - Aalst - Moorselbaan
      • Antwerp, Belgium, 2020
        • Ziekenhuis Aan De Stroom
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liege
      • Liège, Belgium, 4000
        • CHR de la Citadelle
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Hôpital Erasme
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • CHU UCL Namur - Site Godinne
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St.Paul's Hospital
    • Ontario
      • Ajax, Ontario, Canada, L1S2J5
        • Dynamic Drug Advancement Limited
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T7A1
        • Centre d'investigation Clinique Mauricie
  • Chile
    • Maule Region
      • Talca, Maule Region, Chile, 3481349
        • Centro de Investigación del Maule SpA
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500691
        • Instituto Nacional del tórax
      • Santiago, Santiago Metropolitan, Chile, 76302266
        • Fundacion Medica San Cristobal
      • Santiago, Santiago Metropolitan, Chile, 7750495
        • CEC Centro de Estudios Clínicos
    • Valparaiso
      • Quillota, Valparaiso, Chile, 2260000
        • Centro Respiratorio Integral Limitada
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
      • Hellerup, Denmark, 2900
        • Gentofte Hospital - Lungemedicinsk forskningsafdeling
      • Odense C, Denmark, 5000
        • Odense University Hospital - Department of Respiratory Medicine
  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie
      • Bobigny, France, 93000
        • AP-HP - Hopital Avicenne
      • Bron, France, 69500
        • Hospices Civils De Lyon - Université Hospital of Lyon
      • Paris, France, 75018
        • Hôptial Bichat
      • Paris, France, 75015
        • AP-HP - Hôpital Européen Georges Pompidou
      • Reims, France, 51092
        • Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche
      • Rennes, France, 35000
        • Hôpital Pontchaillou
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13015
        • Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille
    • Calvados
      • Caen, Calvados, France, 14000
        • CHU Caen Normandie
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Hopital Larrey
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Hopital Bretonneau
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU Rouen Hopital Charles Nicolle
  • Germany
    • Baden-Wurttemberg
      • Löwenstein, Baden-Wurttemberg, Germany, 74245
        • SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin
    • Bavaria
      • München, Bavaria, Germany, 81377
        • LMU Klinikum der Universität München
      • Rosenheim, Bavaria, Germany, 83022
        • RoMed Klinikum Rosenheim
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45239
        • Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
    • Saxony
      • Coswig, Saxony, Germany, 1640
        • Prufstelle der GWT am Fachkrankenhaus Coswig
    • Thuringia
      • Bad Berka, Thuringia, Germany, 99437
        • Zentralklinik Bad Berka GmbH Klinik für Pneumologie
  • Israel
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Kfar Saba, Israel, 4428100
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center - PPDS
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center - PPDS
    • Central District
      • Rehovot, Central District, Israel, 76100
        • Kaplan Medical Center
    • Haifa District
      • Hadera, Haifa District, Israel, 38100
        • Hillel Yaffe Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah Medical Center - PPDS
    • Southern District
      • Ashkelon, Southern District, Israel, 78278
        • Barzilai Medical Center
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52621
        • Sheba Medical Center - PPDS
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria delle Marche
      • Forlì, Italy, 47121
        • Presidio Ospedaliero GB Morgagni L Pierantoni
      • Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Azienda Ospedaliero Universitaria Di Modena Policlinico
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli-Rome
    • Lombardy
      • Milan, Lombardy, Italy, 20123
        • Gruppo MultiMedica SpA - Ospedale San Giuseppe
    • Sicily
      • Catania, Sicily, Italy, 95123
        • A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Azienda Ospedaliero-Universitaria Senese
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Unidad de Investigación Clínica en Medicina, S.C.
      • Monterrey, Nuevo León, Mexico, 64460
        • Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)
  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum - Heerlen
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus MC -Dr. Molewaterplein 40
  • New Zealand
      • Christchurch, New Zealand, 8013
        • Canterbury Respiratory Research Group
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Waikato Hospital
  • Peru
      • Cusco, Peru, 08002
        • Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
      • Lima, Peru, 15036
        • Clinica Ricardo Palma
      • Lima, Peru, 15046
        • Hospital Central de la Fuerza Aerea del Peru
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seongnam-si, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center, CHA University
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, South Korea, 21565
        • Gachon University Gil Medical Center
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03312
        • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 07061
        • SMG - SNU Boramae Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Granada, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Hospital Universitario Son Espases
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen De La Victoria
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • E-Da Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The University of Alabama at Birmingham
    • Arizona
      • Franklin, Arizona, United States, 37067
        • Clinical Trials Center of Middle Tennessee
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center-Phoenix
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Health
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • Newport Beach, California, United States, 92663
        • NewportNativeMD, Inc
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Health Medical Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health at Shands
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, United States, 32204
        • Ascension St. Vincent's
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Kissimmee, Florida, United States, 34741
        • Pulmonary Disease Specialists, PA d/b/a PDS Research
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
      • St. Petersburg, Florida, United States, 33704
        • Coastal Pulmonary & Critical Care PLC
      • Tampa, Florida, United States, 33606
        • University of South Florida Health
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Piedmont Healthcare Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Pulmonary Specialists
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Healthcare Outpatient Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Science Center Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center
      • Silver Spring, Maryland, United States, 98374
        • Adventist Healthcare White Oak Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Int Med Pulmonary and Critical Care
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Division of Pulmonary and Critical Care Medicine
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University Mississippi Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Lung Research Center, LLC
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Creighton University Clinical Research Office
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Health Sciences Center
    • New York
      • Commack, New York, United States, 11725
        • Stony Brook Advanced Specialty Care
      • New Hyde Park, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27403
        • Pulmonix, LLC
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43201
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S.Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson,Hospital University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health Midlands
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • StatCare Pulmonary Consultants, PLLC
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390-8550
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston, McGovern Medical School
      • McAllen, Texas, United States, 78503
        • A & A Research Consultants, LLC
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center PA
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Health
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health Systems
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Richmond, Virginia, United States, 23230
        • Pulmonary Associates of Richmond, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital and UW Health Clinics
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject gives voluntary informed consent to participate in the study.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Exclusion Criteria:

  1. Subject is pregnant or lactating.
  2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
  3. 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.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Treprostinil
Treprostinil 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.
Device: Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Drug: Inhaled Treprostinil
Inhaled Treprostinil (6 mcg/breath) administered QID
Other Names:
  • Tyvaso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF
Time Frame: Baseline to 6 years
Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs
Baseline to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Therapeutics

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 (Actual)

September 6, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIN-PF-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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