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RECRUITING
NCT05943535
PHASE3

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

Sponsor: United Therapeutics

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

698

Start Date

2023-10-30

Completion Date

2027-11

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo administered QID

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 (150)

UAB Lung Health Center

Birmingham, Alabama, United States

Banner University Medical Center Phoenix Lung Institute

Phoenix, Arizona, United States

Norton Thoracic Institute

Phoenix, Arizona, United States

Peter Morton Medical Building

Los Angeles, California, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

University of California Irvine Medical Center

Orange, California, United States

Paradigm Clinical Research

Redding, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

Paradigm Clinical Research

San Diego, California, United States

Stanford University Medical Center

Stanford, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Ascension Medical Group St. Vincent's Lung Institute

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

Northwestern Memorial Hospital, Clinical Research Unit

Chicago, Illinois, United States

Rush University Medical Center Outpatient Pulmonary Clinic

Chicago, Illinois, United States

UI Health Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

University of Louisville Healthcare Outpatient Research Clinic

Louisville, Kentucky, United States

Tulane Medical Center

New Orleans, 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

Infinity Medical Center

North Dartmouth, Massachusetts, United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, United States

University of Minnesota Health Clinical Research Unit (CRU)

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

The Lung Research Center, LLC

Chesterfield, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

Northwell Health

New Hyde Park, New York, United States

Weill Cornell Medicine, New York-Presbyterian Hospital

New York, New York, United States

Stony Brook Advanced Specialty Care

Stony Brook, 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

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical CEnter

Columbus, Ohio, United States

Mercy Health St.Vincent Medical Center LLC

Toledo, Ohio, United States

Pennsylvania State Hershey Medical Center and College of Medicine

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina-Nexus

Charleston, South Carolina, United States

Prisma Health Pulmonology-Richland

Columbia, South Carolina, United States

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee, United States

StatCare Pulmonary Consultants, PLLC

Knoxville, Tennessee, United States

The Vanderbilt Lung Institute

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center-Advanced Lung Clinic

Dallas, Texas, United States

Houston Methodist Outpatient Center

Houston, Texas, United States

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

Houston, Texas, United States

A & A Research Consultants, LLC

McAllen, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Christopher King, MD

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

Instituto Ave Pulmo - Fundacion enfisema

Mar del Plata, Buenos Aires, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Córdoba Province, Argentina

Sanatorio Parque de Rosario - Consultorios Externos

Rosario, Santa Fe Province, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

CINME Centro de Investigaciones Metabolicas

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Instituto de Medicina Respiratoria

Córdoba, Argentina

Sanatorio Allende Cerro

Córdoba, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Eastern Health Box Hill Hospital

Box Hill, Victoria, Australia

Monash Health-Monash Medical Centre

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Institute for Respiratory Health - Midland

Midland, Western Australia, Australia

Institute for Respiratory Health

Nedlands, Western Australia, Australia

AZORG

Aalst, Belgium

ZAS Middelheim

Antwerp, Belgium

CUB Hopital Erasmde

Brussels, Belgium

Cliniques Universitaires St.-Luc

Brussels, Belgium

UZ Leuven

Leuven, 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

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

CIC Mauricie inc.

Québec, Quebec, Canada

Diex Recherche Inc. - Division Sherbrooke Est

Sherbrooke, Quebec, Canada

Centro de Investigacion Curico

Curicó, Maule Region, Chile

Centro Respiratorio Integral LTDA. (CENRESIN)

Quillota, Región de Valparaíso, Chile

Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)

Viña del Mar, Región de Valparaíso, Chile

CEC Centro Estudios Clinicos

Santiago, Santiago Metropolitan, Chile

Fundacion Medica San Cristobal

Santiago, Santiago Metropolitan, Chile

Biocinetic Ltda.

Santiago, Santiago Metropolitan, Chile

Hôpital Avicennes

Bobigny, France

Hospices civils de Lyon - Hôpital Louis Pradel

Bron, France

CHU Caen Normandie

Caen, France

Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille

Marseille, France

Rouen University Hospital

Rouen, France

Centre Hospitalier Régional Universitaire de Tours

Tours, France

RoMed Klinikum Rosenheim-Ellmaierstr. 23

Rosenheim, Bavaria, Germany

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

Bad Berka, Germany

Prufstelle der GWT am Fachkrankenhaus Coswig

Coswig, Germany

uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, Germany

SLK Kliniken Heilbronn GmbH

Löwenstein, Germany

LMU Klinikum Medizinische Klinik und Poliklinik V

München, Germany

Barzilai Medical Center

Ashkelon, Israel

Hillel Yaffe Medical Center

Hadera, Israel

Rabin Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

The Hadassah University Medical Center Ein Kerem Hospital

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

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

Catania, Italy

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

Forlì, Italy

Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena

Modena, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Canterbury Respiratory Research Group

Christchurch, Canterbury, New Zealand

Aotearoa Clinical Trials Trust- Middlemore Hospital

Auckland, New Zealand

Hospital Nacional Adolfo Guevara Velasco

Cusco, Peru

Clinica Internacional - Sede Lima

Lima, Peru

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

Lima, Peru

Clinica Ricardo Palma

Lima, Peru

Hospital Central de la Fuerza Aerea del Peru

Lima, Peru

Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia

Lima, Peru

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

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

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Royal Papworth Hospital

Cambridge, United Kingdom

NHS Lothian, Royal INfirmary of Edingburgh

Edinburgh, United Kingdom

Guy's Hospital

London, United Kingdom

Manchester University NHS Foundation Trust, North Manchester General Hospital

Manchester, United Kingdom

NHS Tayside, Perth Royal Infirmary

Perth, United Kingdom