Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-OLE)

April 19, 2024 updated by: United Therapeutics

An Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic 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 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). 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 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, 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 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Study Type

Interventional

Enrollment (Estimated)

792

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
      • Ciudad Autónoma de 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 - Fundación enfisema
    • Provincia De Córdoba
      • Córdoba, Provincia De Córdoba, Argentina, 5021
        • Sanatorio Allende Cerro
    • Provincia De Mendoza
      • Mendoza, Provincia De Mendoza, Argentina, 5500
        • Centro Médico INSARES
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • 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
      • Liège, Belgium, 4000
        • CHR de la Citadelle
  • Chile
    • Maule
      • Talca, Maule, Chile, 3481349
        • Centro de Investigación del Maule SpA
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7750495
        • CEC Centro de Estudios Clínicos
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7500691
        • Instituto Nacional del tórax
    • 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
      • Bron, France, 69500
        • Hospices Civils De Lyon - Université Hospital of Lyon
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Hôpital Bretonneau
  • Israel
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Kfar Saba, Israel, 4428100
        • Meir Medical Center
      • Petah Tiqva, Israel, 49100
        • Rabin Medical Center - PPDS
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center - PPDS
    • HaDarom
      • Ashkelon, HaDarom, Israel, 78278
        • Barzilai Medical Center
    • HaMerkaz
      • Rehovot, HaMerkaz, Israel, 76100
        • Kaplan Medical Center
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 52621
        • Sheba Medical Center - PPDS
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Center - PPDS
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Gyeonggido
      • Seongnam-Si, Gyeonggido, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • CHA Bundang Medical Center, CHA University
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Seoul Teugbyeolsi
      • Dongjak-Gu, Seoul Teugbyeolsi, Korea, Republic of, 07061
        • SMG - SNU Boramae Medical Center
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03312
        • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Unidad de Investigación Clínica en Medicina, S.C.
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de Las Nieves
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07120
        • Hospital Universitario Son Espases
    • Barcelona
      • L´Hospitalet de LLobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
  • Taiwan
      • Kaohsiung, Taiwan, 82445
        • E-DA hospital
      • Kaohsiung, 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, 85013
        • St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • 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.
      • 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
      • Saint Petersburg, Florida, United States, 33704
        • Coastal Pulmonary & Critical Care PLC
      • Tampa, Florida, United States, 33606
        • University of South Florida Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • 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
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's 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
    • 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
    • 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
      • New Hyde Park, New York, United States, 11042
        • Northwell Health
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • PulmonIx, LLC
    • 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
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health Midlands
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • StatCare Pulmonary Consultants, PLLC
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • 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
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Richmond, Virginia, United States, 23230
        • Pulmonary Associates of Richmond, Inc.
    • Wisconsin
      • 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 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.
  3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will 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 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.

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
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, 2024

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 (Estimated)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

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

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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