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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Sponsor: United Therapeutics
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
Placebo
Placebo administered QID
Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered QID
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