Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
NCT ID: NCT05943535
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
698 participants
INTERVENTIONAL
2023-10-30
2027-11-30
Brief Summary
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Detailed Description
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Efficacy assessments include spirometry (forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of 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 lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.
Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
Placebo
Placebo administered QID
Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Inhaled Treprostinil
Treprostinil for 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 up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
3. Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
4. Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:
1. Clinically significant decline in % predicted FVC based on ≥10% relative decline
2. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
3. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
5. FVC ≥45% predicted at Screening (confirmed by central review).
6. Subjects must be on 1 of the following:
1. On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
2. Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.
Concomitant use of both nintedanib and pirfenidone is not permitted.
7. Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.
8. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:
1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
2. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.
Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
9. 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.
10. 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
2. Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
3. Subject has a diagnosis of IPF.
4. Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
5. Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments.
6. Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
7. Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
8. Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
9. 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) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
10. Acute pulmonary embolism within 90 days prior to Baseline.
11. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
12. In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.
13. Subject has received nerandomilast within 60 days prior to Baseline.
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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UAB Lung Health Center
Birmingham, Alabama, 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
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
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
Countries
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Central Contacts
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United Therapeutics Global Medical Information
Role: CONTACT
Phone: 919-485-8350
Email: [email protected]
Facility Contacts
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Melessia Wells
Role: primary
Gabrielle Ambrose
Role: primary
Jennifer Perez
Role: primary
Grace Harvey
Role: primary
Jordan Perkins
Role: primary
Mandy Swanson
Role: primary
Sarah Natera
Role: primary
Chery Bolovits
Role: primary
Jannet Estrada
Role: primary
Amen Hamed
Role: primary
Jennifer McWilliams
Role: primary
Inna Dawson
Role: primary
Brenda Farlow
Role: primary
Mitzi Near
Role: primary
Aaron Gundersheimer
Role: primary
Kimberly Saulsberry
Role: primary
Hannah Carlson
Role: primary
Adriana Martinez
Role: primary
Kimberly Lovell
Role: primary
Srushan Shankara bhaktula
Role: primary
Belica Graf
Role: primary
Sandy Ditta
Role: primary
Sarah Collins
Role: primary
Jennifer Hernandez
Role: primary
Mary Hays
Role: primary
Layla Rahimi
Role: primary
Cheryl O'Neil
Role: primary
Beverly Mauer
Role: primary
Amanda DeGrote
Role: primary
Teng Moua
Role: primary
Anna Shipp
Role: primary
Rosann Gans
Role: primary
Megan Baldenweck
Role: primary
Frederick Gentry
Role: primary
Sara Khan
Role: primary
Christine Wu
Role: primary
Jacqueline Skarre
Role: primary
Jane Wilson
Role: primary
Lisa Holmes
Role: primary
Lauren Hinshaw
Role: primary
Shravya Dharambhat
Role: primary
Emillie Hoh
Role: primary
Benjamin Hood
Role: primary
Joseph Bandi
Role: primary
Timothy Sheehan
Role: primary
Sarah Alam
Role: primary
Kim Selwood
Role: primary
Angela Francisco
Role: primary
Keera McKenna
Role: primary
Lindsey Robbs
Role: primary
Tabitha McCauley
Role: primary
Phyllis Young
Role: primary
Brianna Kamran
Role: primary
Maria Goralski
Role: primary
Nelson Villasmil Hernandez
Role: primary
Mary Rangel
Role: primary
Jaedan Chapa
Role: primary
Ambreen Ahmed
Role: primary
Danielle Nasson
Role: primary
Heather Hammerschmidt
Role: primary
Yousef Althulth
Role: primary
Priscila Dauphin
Role: primary
Betsy Daniel
Role: primary
Maggie Chilsen
Role: primary
Kiley Timler
Role: primary
Mario Fernando Sabas
Role: primary
Sebastián Etchevers
Role: primary
Julieta Nasurdi
Role: primary
Maria Jose Guzman
Role: primary
Natalia Juarez Babiano
Role: primary
Yesica Castillo
Role: primary
Antonela Iannazzo
Role: primary
Angélica Baima
Role: primary
Maria Gracia de la Vega
Role: primary
Alan Teoh
Role: primary
Ajantha Raguparan
Role: primary
Alan Carew
Role: primary
Alan Young
Role: primary
Yvonne Ng
Role: primary
Yet Khor
Role: primary
Kaye McMullan
Role: primary
Michelle Young, MD
Role: primary
Elke Hardeman
Role: primary
Johan Clukers
Role: primary
Sebastien Van Laethem
Role: primary
Sophie Gohy
Role: primary
Nico De Crem
Role: primary
Fanny Gester
Role: primary
Jeff Wong
Role: primary
Cynthia Lee
Role: primary
Sarah Goodwin
Role: primary
Danae Tassy
Role: primary
Mireille Devost
Role: primary
Reinaldo Eduardo Cortez de la Fuente
Role: primary
Leon Fernando Ovalle Jarpa
Role: primary
Magdalena Reyes
Role: primary
Nicolas Cataldo
Role: primary
Eliana Andahur Orellana
Role: primary
Beatriz Diaz
Role: primary
Morgane Didier
Role: primary
François Lestelle
Role: primary
Aurélien Justet
Role: primary
Benjamin Coiffard
Role: primary
Hélène Morisse Pradier
Role: primary
Laurent Plantier
Role: primary
Stefan Jungbauer
Role: primary
Veronika Gath
Role: primary
Marcus Vogler
Role: primary
Eda Burcur Börner
Role: primary
Biljana Joves
Role: primary
Tobias Veit
Role: primary
Mohamed Alamor
Role: primary
Marinella Beckerman
Role: primary
Michal Shteinberg
Role: primary
Ariel Rokach
Role: primary
Rottem Kuint
Role: primary
Lilach Israeli-Shani
Role: primary
Maayan Flaschner
Role: primary
Nina Azarov
Role: primary
Irina Fomin
Role: primary
Antonio Galia
Role: primary
Luca Donati
Role: primary
Valentina Ruggieri
Role: primary
Diana Verdirosi
Role: primary
Benedetta Di Ruggiero
Role: primary
Sara Pure
Role: primary
Jennifer Treacy
Role: primary
Rosa Alfaro Carrasco
Role: primary
Eneyda Llerena Zegarra
Role: primary
Alva Silvia
Role: primary
Judith Armas
Role: primary
Franklin Gutierrez Torres
Role: primary
Marjorie Gaviria Haxhuell
Role: primary
Huiyeong Hwang
Role: primary
LeeNa Kim
Role: primary
Mija Kim
Role: primary
Yebin Park
Role: primary
SunHwa Ryu
Role: primary
Hung Yuan-Chen
Role: primary
Yi-Chun Shih
Role: primary
Yi-Chun Shih
Role: primary
Caroline Gallagher
Role: primary
Helen Parfrey
Role: primary
Manjit Cartlidge
Role: primary
Alexandra Lawrence
Role: primary
Huda Badri
Role: primary
Moses Effiong
Role: primary
Other Identifiers
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RIN-PF-305
Identifier Type: -
Identifier Source: org_study_id