Actively Recruiting
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Led by United Therapeutics · Updated on 2026-05-07
698
Participants Needed
153
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject gives voluntary informed consent to participate in the study.
- Subject is 18 years of age or older at the time of signing informed consent.
- Radiological evidence of pulmonary fibrosis affecting more than 10% of the lungs on an HRCT scan within the previous 12 months confirmed by central review.
- Diagnosis of progressive pulmonary fibrosis (other than idiopathic pulmonary fibrosis) with at least one progression criterion within 24 months despite standard treatment: clinically significant decline in FVC (≥10% relative decline), marginal FVC decline (5% to <10%) with worsening respiratory symptoms, marginal FVC decline with increasing fibrotic changes on imaging, or worsening respiratory symptoms with increasing fibrotic changes on imaging.
- Forced vital capacity (FVC) is 45% or greater of predicted at screening confirmed by central review.
- Either on nintedanib or pirfenidone for at least 90 days prior to baseline and planning to continue treatment, or not on these treatments for at least 90 days prior to baseline and not planning to start them during the study; concomitant use of both drugs is not allowed.
- If treated with immunosuppressive agents, treatment must have been ongoing for at least 120 days prior to baseline and refractory to treatment.
- Women of childbearing potential must be non-pregnant and non-lactating and agree to abstain from intercourse or use two effective contraceptive methods during the study and for 30 days after.
- Women who are sterilized or postmenopausal (amenorrhea for at least 12 months) are not considered of reproductive potential.
- Males with partners of childbearing potential must agree to use condoms during treatment and for 48 hours after discontinuation.
- Ability to communicate effectively with study personnel and willingness to comply with study procedures and attend all visits.
You will not qualify if you...
- Subject is pregnant or lactating.
- Primary obstructive airway physiology (FEV1/FVC ratio less than 0.70) or greater emphysema than fibrosis on HRCT.
- Diagnosis of idiopathic pulmonary fibrosis (IPF).
- Intolerance or significant lack of efficacy to prostacyclin or analogues causing discontinuation or inability to titrate therapy.
- Use of pulmonary arterial hypertension (PAH)-approved therapies including prostacyclin therapy, IP receptor agonists, endothelin receptor antagonists, PDE5 inhibitors, soluble guanylate cyclase stimulators, or activin signaling inhibitors within 60 days prior to baseline, except as needed PDE5-I use for erectile dysfunction without doses within 48 hours before efficacy assessments.
- Receiving oxygen supplementation over 10 L/min at rest at baseline.
- Exacerbation of interstitial lung disease or active pulmonary/upper respiratory infection within 30 days prior to baseline, with specific timing requirements after treatment or hospitalization.
- Uncontrolled cardiac disease such as recent myocardial infarction or unstable angina.
- Participation in investigational drug/device studies with medical interventions within 30 days prior to screening; non-interventional studies are allowed.
- Acute pulmonary embolism within 90 days prior to baseline.
- Any condition interfering with study assessments or participation as judged by the investigator.
- Life expectancy less than 12 months due to ILD or other illness.
- Use of nerandomilast within 60 days prior to baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 153 locations
1
UAB Lung Health Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner University Medical Center Phoenix Lung Institute
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
Norton Thoracic Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
4
Peter Morton Medical Building
Los Angeles, California, United States, 90095
Actively Recruiting
5
NewportNativeMD, Inc.
Newport Beach, California, United States, 92663
Actively Recruiting
6
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
7
Paradigm Clinical Research
Redding, California, United States, 45227
Actively Recruiting
8
UC Davis Health Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
9
Paradigm Clinical Research
San Diego, California, United States, 92108
Actively Recruiting
10
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
11
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
12
Ascension Medical Group St. Vincent's Lung Institute
Jacksonville, Florida, United States, 32204
Actively Recruiting
13
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
14
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida, United States, 33606
Actively Recruiting
15
The Emory Clinic
Atlanta, Georgia, United States, 45227
Actively Recruiting
16
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, Illinois, United States, 60612
Actively Recruiting
18
UI Health Hospital
Chicago, Illinois, United States, 60612
Actively Recruiting
19
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
20
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
University of Kentucky
Lexington, Kentucky, United States, 45227
Actively Recruiting
22
University of Louisville Healthcare Outpatient Research Clinic
Louisville, Kentucky, United States, 40202
Actively Recruiting
23
Tulane Medical Center
New Orleans, Louisiana, United States, 45227
Actively Recruiting
24
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
25
University of Maryland Medical Center
Baltimore, Maryland, United States, 45227
Actively Recruiting
26
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland, United States, 20904
Actively Recruiting
27
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
28
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
29
Infinity Medical Center
North Dartmouth, Massachusetts, United States, 02747
Actively Recruiting
30
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States, 48073
Actively Recruiting
31
University of Minnesota Health Clinical Research Unit (CRU)
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
32
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
33
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States, 39501
Actively Recruiting
34
The Lung Research Center, LLC
Chesterfield, Missouri, United States, 63017
Actively Recruiting
35
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
36
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
37
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
38
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
39
Weill Cornell Medicine, New York-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
40
Stony Brook Advanced Specialty Care
Stony Brook, New York, United States, 11794-8172
Actively Recruiting
41
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
42
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
43
PulmonIx LLC
Greensboro, North Carolina, United States, 27403
Actively Recruiting
44
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
45
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104
Actively Recruiting
46
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
47
The Ohio State University Wexner Medical CEnter
Columbus, Ohio, United States, 43201
Actively Recruiting
48
Mercy Health St.Vincent Medical Center LLC
Toledo, Ohio, United States, 43608
Actively Recruiting
49
Pennsylvania State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
50
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
51
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
52
Medical University of South Carolina-Nexus
Charleston, South Carolina, United States, 29425
Actively Recruiting
53
Prisma Health Pulmonology-Richland
Columbia, South Carolina, United States, 29203
Actively Recruiting
54
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States, 37067
Actively Recruiting
55
StatCare Pulmonary Consultants, PLLC
Knoxville, Tennessee, United States, 37919
Actively Recruiting
56
The Vanderbilt Lung Institute
Nashville, Tennessee, United States, 37204
Actively Recruiting
57
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
58
UT Southwestern Medical Center-Advanced Lung Clinic
Dallas, Texas, United States, 75390
Actively Recruiting
59
Houston Methodist Outpatient Center
Houston, Texas, United States, 77030
Actively Recruiting
60
The University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
61
A & A Research Consultants, LLC
McAllen, Texas, United States, 78503
Actively Recruiting
62
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States, 75069
Actively Recruiting
63
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
64
University of Utah Health
Salt Lake City, Utah, United States, 84108
Actively Recruiting
65
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
66
Christopher King, MD
Falls Church, Virginia, United States, 22042
Actively Recruiting
67
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States, 23230
Actively Recruiting
68
University Hospital and UW Health Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
69
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-1222
Actively Recruiting
70
Instituto Ave Pulmo - Fundacion enfisema
Mar del Plata, Buenos Aires, Argentina, 7600
Actively Recruiting
71
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, Argentina, 5800
Actively Recruiting
72
Sanatorio Parque de Rosario - Consultorios Externos
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
73
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
74
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina
Actively Recruiting
75
CINME Centro de Investigaciones Metabolicas
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
76
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Actively Recruiting
77
Instituto de Medicina Respiratoria
Córdoba, Argentina, 5003
Actively Recruiting
78
Sanatorio Allende Cerro
Córdoba, Argentina, 5021
Actively Recruiting
79
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
80
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
81
The Prince Charles Hospital
Brisbane, Queensland, Australia, Australia
Actively Recruiting
82
Eastern Health Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
83
Monash Health-Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
84
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
85
Institute for Respiratory Health - Midland
Midland, Western Australia, Australia, 6056
Actively Recruiting
86
Institute for Respiratory Health
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
87
AZORG
Aalst, Belgium, 9300
Actively Recruiting
88
ZAS Middelheim
Antwerp, Belgium, 2020
Actively Recruiting
89
CUB Hopital Erasmde
Brussels, Belgium, 1070
Actively Recruiting
90
Cliniques Universitaires St.-Luc
Brussels, Belgium, 1200
Actively Recruiting
91
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
92
CHU de Liège
Liège, Belgium, 4000
Actively Recruiting
93
St.Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 176
Actively Recruiting
94
Dynamic Drug Advancement Limited
Ajax, Ontario, Canada, L1S 2J5
Actively Recruiting
95
St.Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
96
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
97
CIC Mauricie inc.
Québec, Quebec, Canada, G8T 7A1
Actively Recruiting
98
Diex Recherche Inc. - Division Sherbrooke Est
Sherbrooke, Quebec, Canada, J1E 0N8
Actively Recruiting
99
Centro de Investigacion Curico
Curicó, Maule Region, Chile, 3341643
Actively Recruiting
100
CEC Centro Estudios Clinicos
Santiago, Santiago Metropolitan, Chile, 7550495
Actively Recruiting
101
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan, Chile, 7630226
Actively Recruiting
102
Biocinetic Ltda.
Santiago, Santiago Metropolitan, Chile, 8320000
Actively Recruiting
103
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Valparaiso, Chile, 2260000
Actively Recruiting
104
Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)
Viña del Mar, Valparaiso, Chile, 2520000
Actively Recruiting
105
Hôpital Avicennes
Bobigny, France, 93000
Actively Recruiting
106
Hospices civils de Lyon - Hôpital Louis Pradel
Bron, France, 69500
Actively Recruiting
107
CHU Caen Normandie
Caen, France, 14000
Actively Recruiting
108
Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille
Marseille, France
Actively Recruiting
109
Rouen University Hospital
Rouen, France, 7600
Actively Recruiting
110
Centre Hospitalier Régional Universitaire de Tours
Tours, France, Tours Cedex 9
Actively Recruiting
111
RoMed Klinikum Rosenheim-Ellmaierstr. 23
Rosenheim, Bavaria, Germany, 83022
Actively Recruiting
112
Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin
Bad Berka, Germany, 99437
Actively Recruiting
113
Prufstelle der GWT am Fachkrankenhaus Coswig
Coswig, Germany, 01640
Actively Recruiting
114
uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45239
Actively Recruiting
115
SLK Kliniken Heilbronn GmbH
Löwenstein, Germany, 74245
Actively Recruiting
116
LMU Klinikum Medizinische Klinik und Poliklinik V
München, Germany, 81377
Actively Recruiting
117
Barzilai Medical Center
Ashkelon, Israel, 7830604
Actively Recruiting
118
Hillel Yaffe Medical Center
Hadera, Israel, 3846201
Actively Recruiting
119
Rabin Medical Center
Haifa, Israel, 3436212
Actively Recruiting
120
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
121
The Hadassah University Medical Center Ein Kerem Hospital
Jerusalem, Israel, 9112001
Actively Recruiting
122
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
123
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
124
Kaplan Medical Center
Rehovot, Israel, 7551041
Actively Recruiting
125
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
126
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Presidio Ospedaliero Gaspare Rodolico
Catania, Italy, 95123
Actively Recruiting
127
Azienda Unita Sanitaria Locale Della Romagna Ospedale "Gian Battista Morgagni - Luigi Pierantoni" di Forlì
Forlì, Italy, 47121
Actively Recruiting
128
Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena
Modena, Italy, 41124
Actively Recruiting
129
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 168
Actively Recruiting
130
Azienda Ospedaliero-Universitaria Senese
Siena, Italy, 53100
Actively Recruiting
131
Canterbury Respiratory Research Group
Christchurch, Canterbury, New Zealand, 8011
Actively Recruiting
132
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland, New Zealand
Actively Recruiting
133
Waikato Hospital
Hamilton, New Zealand, 3204
Actively Recruiting
134
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru, 08002
Actively Recruiting
135
Clinica Internacional - Sede Lima
Lima, Peru, 15001
Actively Recruiting
136
Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco
Lima, Peru, 15023
Actively Recruiting
137
Clinica Ricardo Palma
Lima, Peru, 15036
Actively Recruiting
138
Hospital Central de la Fuerza Aerea del Peru
Lima, Peru, 15046
Actively Recruiting
139
Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia
Lima, Peru, 15088
Actively Recruiting
140
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
141
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
142
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
143
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
144
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea, 3312
Actively Recruiting
145
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
146
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
147
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
148
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Actively Recruiting
149
Royal Papworth Hospital
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
150
NHS Lothian, Royal INfirmary of Edingburgh
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
151
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
152
Manchester University NHS Foundation Trust, North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Actively Recruiting
153
NHS Tayside, Perth Royal Infirmary
Perth, United Kingdom, PH1 1NX
Actively Recruiting
Research Team
U
United Therapeutics Global Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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