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ENROLLING BY INVITATION
NCT04905693
PHASE3

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Sponsor: United Therapeutics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1850

Start Date

2022-09-06

Completion Date

2026-06

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Inhaled Treprostinil

Inhaled Treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

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

Locations (193)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Clinical Trials Center of Middle Tennessee

Franklin, Arizona, United States

Banner University Medical Center-Phoenix

Phoenix, Arizona, United States

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

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

UC San Diego Health

La Jolla, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

NewportNativeMD, Inc

Newport Beach, California, United States

Palmtree Clinical Research, Inc.

Palm Springs, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University School of Medicine

Stanford, California, United States

National Jewish Health

Denver, Colorado, United States

University of Florida Health at Shands

Gainesville, Florida, United States

Ascension St. Vincent's

Jacksonville, Florida, United States

University of Florida

Jacksonville, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

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

Kissimmee, Florida, United States

Central Florida Pulmonary Group, PA

Orlando, Florida, United States

Coastal Pulmonary & Critical Care PLC

St. Petersburg, Florida, United States

University of South Florida Health

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Piedmont Healthcare Atlanta

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

University of Louisville Healthcare Outpatient Center

Louisville, Kentucky, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

LSU Health Science Center Shreveport

Shreveport, Louisiana, United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Adventist Healthcare White Oak Medical Center

Silver Spring, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Int Med Pulmonary and critical care

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health William Beaumont Hospital

Royal Oak, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic, Division of Pulmonary and Critical Care Medicine

Rochester, Minnesota, United States

University Mississippi Medical Center

Jackson, Mississippi, United States

The Lung Research Center, LLC

Chesterfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Creighton University Clinical Research Office

Omaha, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Stony Brook Advanced Specialty Care

Commack, New York, United States

Northwell Health

New Hyde Park, New York, United States

Weill Cornell Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

PulmonIx, LLC

Greensboro, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

The Oregon Clinic

Portland, Oregon, United States

Penn State Milton S.Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson,Hospital University

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Midlands

Columbia, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

StatCare Pulmonary Consultants, PLLC

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

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

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

A & A Research Consultants, LLC

McAllen, Texas, United States

Metroplex Pulmonary and Sleep Center PA

McKinney, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

Intermountain Healthcare

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia Health Systems

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

University Hospital and UW Health Clinics

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

CINME S.A. - Centro de Investigaciones Metabólicas

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Ave Pulmo - Fundación enfisema

Mar del Plata, Buenos Aires, Argentina

Sanatorio Allende Cerro

Córdoba, Córdoba Province, Argentina

Instituto Medico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Centro Médico INSARES

Mendoza, Mendoza Province, Argentina

Sanatorio Parque de Rosario - Consultorios Externos

Rosario, Santa Fe Province, Argentina

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Médico Dra. De Salvo

Buenos Aires, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Macquarie University

Macquarie Park, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Cairns Hospital

Cairns, Queensland, Australia

Lung Research Qld

Chermside, Queensland, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Mater Misericordiae Ltd

South Brisbane, Queensland, Australia

Alfred Health

Melbourne, Victoria, Australia

Hôpital Erasme

Anderlecht, Brussels Capital, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Namur, Belgium

vzw AZORG - Aalst - Moorselbaan

Aalst, Belgium

Ziekenhuis Aan de Stroom

Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

CHR de la Citadelle

Liège, Belgium

CHU de Liège

Liège, Belgium

St.Paul's Hospital

Vancouver, British Columbia, Canada

Dynamic Drug Advancement Limited

Ajax, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada

Centro de Investigación del Maule SpA

Talca, Maule Region, Chile

Centro Respiratorio Integral Limitada

Quillota, Región de Valparaíso, Chile

Instituto Nacional del tórax

Santiago, Santiago Metropolitan, Chile

Fundación Médica San Cristobal

Santiago, Santiago Metropolitan, Chile

CEC Centro de Estudios Clínicos

Santiago, Santiago Metropolitan, Chile

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

Aarhus N, Denmark

Gentofte Hospital - Lungemedicinsk forskningsafdeling

Hellerup, Denmark

Odense University Hospital - Department of Respiratory Medicine

Odense C, Denmark

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

Marseille, Bouches-du-Rhône, France

CHU Caen Normandie

Caen, Calvados, France

Hopital Larrey

Toulouse, Haute-Garonne, France

Hôpital Bretonneau

Tours, Indre-et-Loire, France

CHU Rouen Hopital Charles Nicolle

Rouen, Seine-Maritime, France

CHU Amiens-Picardie

Amiens, France

AP-HP - Hopital Avicenne

Bobigny, France

Hospices Civils De Lyon - Université Hospital of Lyon

Bron, France

AP-HP - Hôpital Européen Georges Pompidou

Paris, France

Hôptial Bichat

Paris, France

Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche

Reims, France

Hôpital Pontchaillou

Rennes, France

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

Löwenstein, Baden-Wurttemberg, Germany

LMU Klinikum der Universität München

München, Bavaria, Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, North Rhine-Westphalia, Germany

Prüfstelle der GWT am Fachkrankenhaus Coswig

Coswig, Saxony, Germany

Zentralklinik Bad Berka GmbH Klinik für Pneumologie

Bad Berka, Thuringia, Germany

Kaplan Medical Center

Rehovot, Central District, Israel

Hillel Yaffe Medical Center

Hadera, Haifa District, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Hadassah Medical Center - PPDS

Jerusalem, Jerusalem, Israel

Barzilai Medical Center

Ashkelon, Southern District, Israel

Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, Israel

Lady Davis Carmel Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center - PPDS

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center - PPDS

Tel Aviv, Israel

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Emilia-Romagna, Italy

Fondazione Policlinico Universitario A Gemelli-Rome

Rome, Lazio, Italy

Gruppo MultiMedica SpA - Ospedale San Giuseppe

Milan, Lombardy, Italy

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

Catania, Sicily, Italy

Azienda ospedaliero-universitaria Senese

Siena, Tuscany, Italy

Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy

Presidio Ospedaliero GB Morgagni L Pierantoni

Forlì, Italy

Fondazione PTV Policlinico Tor Vergata

Roma, Italy

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

Monterrey, Nuevo León, Mexico

Unidad de Investigación Clínica en Medicina, S.C.

Monterrey, Nuevo León, Mexico

Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

Mexico City, Mexico

Zuyderland Medisch Centrum - Heerlen

Heerlen, Limburg, Netherlands

Erasmus MC -Dr. Molewaterplein 40

Rotterdam, South Holland, Netherlands

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Canterbury Respiratory Research Group

Christchurch, New Zealand

Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco

Cusco, Peru

Clinica Ricardo Palma

Lima, Peru

Hospital Central de la Fuerza Aérea del Perú

Lima, Peru

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggido, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, South Korea

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

Seoul, Seoul Teugbyeolsi, South Korea

SMG - SNU Boramae Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Clinico Universitario Virgen de La Arrixaca

Murcia, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

E-DA hospital

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan