Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
NCT ID: NCT04905693
Last Updated: 2026-01-20
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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ENROLLING_BY_INVITATION
PHASE3
1850 participants
INTERVENTIONAL
2022-09-06
2026-06-30
Brief Summary
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Detailed Description
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Efficacy assessments will include spirometry (forced expiratory volume in 1 second \[FEV1\] and forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of IPF or 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 diffusion capacity of lungs for carbon monoxide (DLCO). Safety assessments will include monitoring for the development of AEs/SAEs, vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. In addition, up to 24 eligible subjects with IPF rolling over from Study RIN-PF-301 and up to 24 eligible subjects with PPF rolling over from Study RIN-PF-305 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inhaled Treprostinil
Treprostinil 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 to a target of 15 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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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. The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
4. 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.
5. 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. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
3. 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). Subjects participating in non-interventional, observational, or registry studies are eligible.
40 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Clinical Trials Center of Middle Tennessee
Franklin, Arizona, United States
Banner University Medical Center-Phoenix
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
UC San Diego Health
La Jolla, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
NewportNativeMD, Inc
Newport Beach, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
UC Davis Health Medical Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University School of Medicine
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
University of Florida Health at Shands
Gainesville, Florida, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
University of Florida
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Pulmonary Disease Specialists, PA d/b/a PDS Research
Kissimmee, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Coastal Pulmonary & Critical Care PLC
St. Petersburg, Florida, United States
University of South Florida Health
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Piedmont Healthcare Atlanta
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
University of Louisville Healthcare Outpatient Center
Louisville, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
LSU Health Science Center Shreveport
Shreveport, 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
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Int Med Pulmonary and critical care
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health William Beaumont Hospital
Royal Oak, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Division of Pulmonary and Critical Care Medicine
Rochester, Minnesota, United States
University Mississippi Medical Center
Jackson, Mississippi, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Creighton University Clinical Research Office
Omaha, Nebraska, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Stony Brook Advanced Specialty Care
Commack, New York, United States
Northwell Health
New Hyde Park, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PulmonIx, LLC
Greensboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
Penn State Milton S.Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson,Hospital University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Midlands
Columbia, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
StatCare Pulmonary Consultants, PLLC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
A & A Research Consultants, LLC
McAllen, Texas, United States
Metroplex Pulmonary and Sleep Center PA
McKinney, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Intermountain Healthcare
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Inova Fairfax Hospital
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
CINME S.A. - Centro de Investigaciones Metabólicas
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Ave Pulmo - Fundación enfisema
Mar del Plata, Buenos Aires, Argentina
Sanatorio Allende Cerro
Córdoba, Córdoba Province, Argentina
Instituto Medico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Centro Médico INSARES
Mendoza, Mendoza Province, Argentina
Sanatorio Parque de Rosario - Consultorios Externos
Rosario, Santa Fe Province, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Médico Dra. De Salvo
Buenos Aires, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Macquarie University
Macquarie Park, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
Lung Research Qld
Chermside, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
Hôpital Erasme
Anderlecht, Brussels Capital, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Namur, Belgium
vzw AZORG - Aalst - Moorselbaan
Aalst, , Belgium
Ziekenhuis Aan de Stroom
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
CHR de la Citadelle
Liège, , 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
Toronto General Hospital
Toronto, Ontario, Canada
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, , Canada
Centro de Investigación del Maule SpA
Talca, Maule Region, Chile
Centro Respiratorio Integral Limitada
Quillota, Región de Valparaíso, Chile
Instituto Nacional del tórax
Santiago, Santiago Metropolitan, Chile
Fundación Médica San Cristobal
Santiago, Santiago Metropolitan, Chile
CEC Centro de Estudios Clínicos
Santiago, Santiago Metropolitan, Chile
Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
Aarhus N, , Denmark
Gentofte Hospital - Lungemedicinsk forskningsafdeling
Hellerup, , Denmark
Odense University Hospital - Department of Respiratory Medicine
Odense C, , Denmark
Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille
Marseille, Bouches-du-Rhône, France
CHU Caen Normandie
Caen, Calvados, France
Hopital Larrey
Toulouse, Haute-Garonne, France
Hôpital Bretonneau
Tours, Indre-et-Loire, France
CHU Rouen Hopital Charles Nicolle
Rouen, Seine-Maritime, France
CHU Amiens-Picardie
Amiens, , France
AP-HP - Hopital Avicenne
Bobigny, , France
Hospices Civils De Lyon - Université Hospital of Lyon
Bron, , France
AP-HP - Hôpital Européen Georges Pompidou
Paris, , France
Hôptial Bichat
Paris, , France
Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche
Reims, , France
Hôpital Pontchaillou
Rennes, , France
SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin
Löwenstein, Baden-Wurttemberg, Germany
LMU Klinikum der Universität München
München, Bavaria, Germany
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, Germany
Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, North Rhine-Westphalia, Germany
Prüfstelle der GWT am Fachkrankenhaus Coswig
Coswig, Saxony, Germany
Zentralklinik Bad Berka GmbH Klinik für Pneumologie
Bad Berka, Thuringia, Germany
Kaplan Medical Center
Rehovot, Central District, Israel
Hillel Yaffe Medical Center
Hadera, Haifa District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Barzilai Medical Center
Ashkelon, Southern District, Israel
Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center - PPDS
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Rome, Lazio, Italy
Gruppo MultiMedica SpA - Ospedale San Giuseppe
Milan, Lombardy, Italy
A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
Catania, Sicily, Italy
Azienda ospedaliero-universitaria Senese
Siena, Tuscany, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, , Italy
Presidio Ospedaliero GB Morgagni L Pierantoni
Forlì, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)
Monterrey, Nuevo León, Mexico
Unidad de Investigación Clínica en Medicina, S.C.
Monterrey, Nuevo León, Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
Mexico City, , Mexico
Zuyderland Medisch Centrum - Heerlen
Heerlen, Limburg, Netherlands
Erasmus MC -Dr. Molewaterplein 40
Rotterdam, South Holland, Netherlands
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Canterbury Respiratory Research Group
Christchurch, , New Zealand
Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
Cusco, , Peru
Clinica Ricardo Palma
Lima, , Peru
Hospital Central de la Fuerza Aérea del Perú
Lima, , Peru
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea
SMG - SNU Boramae Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
E-DA hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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RIN-PF-302
Identifier Type: -
Identifier Source: org_study_id
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