Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
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)
1 other identifier
interventional
698
15 countries
159
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Typical duration for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
June 4, 2026
June 1, 2026
4 years
July 5, 2023
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Absolute FVC from Baseline to Week 52
The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Baseline to Week 52
Secondary Outcomes (6)
Time to First Clinical Worsening
Baseline to Week 52
Time to First Acute Exacerbation of ILD
Baseline to Week 52
Overall Survival at Week 52
Week 52
Change in % Predicted FVC from Baseline to Week 52
Baseline to Week 52
Change in K-BILD Questionnaire Score from Baseline to Week 52
Baseline to Week 52
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching placebo inhaled using an ultrasonic nebulizer QID
Inhaled Treprostinil
EXPERIMENTALTreprostinil 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.
Interventions
Inhaled treprostinil (6 mcg/breath) administered QID
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Eligibility Criteria
You may qualify if:
- Subject gives voluntary informed consent to participate in the study.
- Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
- Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
- 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:
- Clinically significant decline in % predicted FVC based on ≥10% relative decline
- Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
- Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
- Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
- FVC ≥45% predicted at Screening (confirmed by central review).
- Subjects must be on 1 of the following:
- On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
- 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.
- 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.
- 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:
- +6 more criteria
You may not qualify if:
- Subject is pregnant or lactating.
- 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).
- Subject has a diagnosis of IPF.
- 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.
- 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.
- Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
- 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.
- Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
- 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.
- Acute pulmonary embolism within 90 days prior to Baseline.
- 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.
- In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.
- Subject has received nerandomilast within 60 days prior to Baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (159)
UAB Lung Health Center
Birmingham, Alabama, 35233, United States
Banner University Medical Center Phoenix Lung Institute
Phoenix, Arizona, 85006, United States
Norton Thoracic Institute
Phoenix, Arizona, 85013, United States
Peter Morton Medical Building
Los Angeles, California, 90095, United States
NewportNativeMD, Inc.
Newport Beach, California, 92663, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Paradigm Clinical Research
Redding, California, 45227, United States
UC Davis Health Medical Center
Sacramento, California, 95817, United States
Paradigm Clinical Research
San Diego, California, 92108, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Ascension Medical Group St. Vincent's Lung Institute
Jacksonville, Florida, 32204, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida, 33606, United States
The Emory Clinic
Atlanta, Georgia, 45227, United States
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, 60611, United States
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, Illinois, 60612, United States
UI Health Hospital
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 45227, United States
University of Louisville Healthcare Outpatient Research Clinic
Louisville, Kentucky, 40202, United States
Tulane Medical Center
New Orleans, Louisiana, 45227, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
University of Maryland Medical Center
Baltimore, Maryland, 45227, United States
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland, 20904, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Infinity Medical Center
North Dartmouth, Massachusetts, 02747, United States
Corewell Health Grand Rapids Hospitals - Butterworth
Grand Rapids, Michigan, 49503, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073, United States
University of Minnesota Health Clinical Research Unit (CRU)
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Weill Cornell Medicine, New York-Presbyterian Hospital
New York, New York, 10065, United States
Stony Brook Advanced Specialty Care
Stony Brook, New York, 11794-8172, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
PulmonIx LLC
Greensboro, North Carolina, 27403, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
The Ohio State University Wexner Medical CEnter
Columbus, Ohio, 43201, United States
Mercy Health St.Vincent Medical Center LLC
Toledo, Ohio, 43608, United States
Pennsylvania State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina-Nexus
Charleston, South Carolina, 29425, United States
Prisma Health Pulmonology-Richland
Columbia, South Carolina, 29203, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067, United States
StatCare Pulmonary Consultants, PLLC
Knoxville, Tennessee, 37919, United States
The Vanderbilt Lung Institute
Nashville, Tennessee, 37204, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center-Advanced Lung Clinic
Dallas, Texas, 75390, United States
Houston Methodist Outpatient Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, 77030, United States
A & A Research Consultants, LLC
McAllen, Texas, 78503, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah Health
Salt Lake City, Utah, 84108, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Christopher King, MD
Falls Church, Virginia, 22042, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222, United States
Instituto Ave Pulmo - Fundacion enfisema
Mar del Plata, Buenos Aires, 7600, Argentina
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, 5800, Argentina
Sanatorio Parque de Rosario - Consultorios Externos
Rosario, Santa Fe Province, 2000, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina
CINME Centro de Investigaciones Metabolicas
Buenos Aires, C1056ABI, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Instituto de Medicina Respiratoria
Córdoba, 5003, Argentina
Sanatorio Allende Cerro
Córdoba, 5021, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia, Australia
Eastern Health Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Health-Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Institute for Respiratory Health - Midland
Midland, Western Australia, 6056, Australia
Institute for Respiratory Health
Nedlands, Western Australia, 6009, Australia
AZORG
Aalst, 9300, Belgium
ZAS Middelheim
Antwerp, 2020, Belgium
CUB Hopital Erasmde
Brussels, 1070, Belgium
Cliniques Universitaires St.-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
St.Paul's Hospital
Vancouver, British Columbia, V6Z 176, Canada
Dynamic Drug Advancement Limited
Ajax, Ontario, L1S 2J5, Canada
St.Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
CIC Mauricie inc.
Québec, Quebec, G8T 7A1, Canada
Diex Recherche Inc. - Division Sherbrooke Est
Sherbrooke, Quebec, J1E 0N8, Canada
Centro de Investigacion Curico
Curicó, Maule Region, 3341643, Chile
CEC Centro Estudios Clinicos
Santiago, Santiago Metropolitan, 7550495, Chile
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan, 7630226, Chile
Biocinetic Ltda.
Santiago, Santiago Metropolitan, 8320000, Chile
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Valparaiso, 2260000, Chile
Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)
Viña del Mar, Valparaiso, 2520000, Chile
Hôpital Avicennes
Bobigny, 93000, France
Hospices civils de Lyon - Hôpital Louis Pradel
Bron, 69500, France
CHU Caen Normandie
Caen, 14000, France
Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille
Marseille, France
Rouen University Hospital
Rouen, 7600, France
Centre Hospitalier Régional Universitaire de Tours
Tours, Tours Cedex 9, France
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, Bavaria, 97702, Germany
RoMed Klinikum Rosenheim-Ellmaierstr. 23
Rosenheim, Bavaria, 83022, Germany
Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin
Bad Berka, 99437, Germany
Prufstelle der GWT am Fachkrankenhaus Coswig
Coswig, 01640, Germany
uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
SLK Kliniken Heilbronn GmbH
Löwenstein, 74245, Germany
LMU Klinikum Medizinische Klinik und Poliklinik V
München, 81377, Germany
Barzilai Medical Center
Ashkelon, 7830604, Israel
Hillel Yaffe Medical Center
Hadera, 3846201, Israel
Rabin Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
The Hadassah University Medical Center Ein Kerem Hospital
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 7551041, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Presidio Ospedaliero Gaspare Rodolico
Catania, 95123, Italy
Azienda Unita Sanitaria Locale Della Romagna Ospedale "Gian Battista Morgagni - Luigi Pierantoni" di Forlì
Forlì, 47121, Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena
Modena, 41124, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168, Italy
Azienda Ospedaliero-Universitaria Senese
Siena, 53100, Italy
Centro Ricerche Cliniche di Verona SrL Pneumology Unit
Verona, 37134, Italy
Canterbury Respiratory Research Group
Christchurch, Canterbury, 8011, New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Hospital Nacional Adolfo Guevara Velasco
Cusco, 08002, Peru
Clinica Internacional - Sede Lima
Lima, 15001, Peru
Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco
Lima, 15023, Peru
Clinica Ricardo Palma
Lima, 15036, Peru
Hospital Central de la Fuerza Aerea del Peru
Lima, 15046, Peru
Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia
Lima, 15088, Peru
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 3312, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Papworth Hospital
Cambridge, CB2 0AY, United Kingdom
NHS Lothian, Royal INfirmary of Edingburgh
Edinburgh, EH16 4SA, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Manchester University NHS Foundation Trust, North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
NHS Tayside, Perth Royal Infirmary
Perth, PH1 1NX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2023
First Posted
July 13, 2023
Study Start
October 30, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
June 4, 2026
Record last verified: 2026-06