Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary FibrosisInterstitial Lung Disease
- Interventions
- Device: Treprostinil Ultrasonic Nebulizer
- Registration Number
- NCT04905693
- Lead Sponsor
- United Therapeutics
- Brief Summary
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.
- Detailed Description
Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF, or the study is discontinued by the Sponsor (whichever is sooner).
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, 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 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 792
- Subject gives voluntary informed consent to participate in the study.
- The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.
- Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will 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.
- Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- 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.
- Subject is pregnant or lactating.
- In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaled Treprostinil 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 Treprostinil Ultrasonic Nebulizer 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.
- Primary Outcome Measures
Name Time Method Long-term safety and tolerability of inhaled treprostinil in subjects with IPF Baseline to 6 years Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (182)
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
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Int Med Pulmonary and critical care
🇺🇸Ann Arbor, Michigan, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
vzw AZORG - Aalst - Moorselbaan
🇧🇪Aalst, Belgium
Ziekenhuis Aan de Stroom
🇧🇪Antwerpen, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHR de la Citadelle
🇧🇪Liège, Belgium
CHU de Liège
🇧🇪Liège, Belgium
Dynamic Drug Advancement Limited
🇨🇦Ajax, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, 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, Chile
CEC Centro de Estudios Clínicos
🇨🇱Santiago, Metropolitana, Chile
Hopital Larrey
🇫🇷Toulouse, Haute-Garonne, France
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
🇲🇽Ciudad de Mexico, Mexico
Zuyderland Medisch Centrum - Heerlen
🇳🇱Heerlen, Limburg, Netherlands
Erasmus MC -Dr. Molewaterplein 40
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Waikato Hospital
🇳🇿Hamilton, Waikato, New Zealand
Canterbury Respiratory Research Group
🇳🇿Christchurch, New Zealand
Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
🇵🇪Cusco, Peru
Clinica Ricardo Palma
🇵🇪Lima, Peru
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
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
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
🇺🇸Saint 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
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
🇺🇸Saint 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
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, 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 College of Medicine
🇺🇸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, Provincia De Córdoba, Argentina
Instituto Medico Río Cuarto
🇦🇷Rio Cuarto, Provincia De Córdoba, Argentina
Centro Médico INSARES
🇦🇷Mendoza, Provincia De Mendoza, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Investigaciones en Patologías Respiratorias
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Centro Médico Dra. De Salvo
🇦🇷Ciudad Autónoma de 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
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, Belgium
CHU UCL Namur - Site Godinne
🇧🇪Yvoir, Namur, Belgium
Instituto Nacional del tórax
🇨🇱Santiago, Región Metropolitana, Chile
Fundación Médica San Cristobal
🇨🇱Santiago, Región Metropolitana, Chile
Centro Respiratorio Integral Limitada
🇨🇱Quillota, Valparaiso, 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
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
Tel Aviv Sourasky Medical Center - PPDS
🇮🇱Tel Aviv, Israel
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-Württemberg, Germany
LMU Klinikum der Universität München
🇩🇪München, Bayern, Germany
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Bayern, Germany
Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Nordrhein-Westfalen, Germany
Prüfstelle der GWT am Fachkrankenhaus Coswig
🇩🇪Coswig, Sachsen, Germany
Zentralklinik Bad Berka GmbH Klinik für Pneumologie
🇩🇪Bad Berka, Thüringen, Germany
Barzilai Medical Center
🇮🇱Ashkelon, HaDarom, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, Haifa, Israel
Kaplan Medical Center
🇮🇱Rehovot, HaMerkaz, Israel
Sheba Medical Center - PPDS
🇮🇱Ramat Gan, Tel-Aviv, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Hadassah Medical Center - PPDS
🇮🇱Jerusalem, Yerushalayim, Israel
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center - PPDS
🇮🇱Petah Tiqva, Israel
Azienda Ospedaliero Universitaria Di Modena Policlinico
🇮🇹Modena, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
🇮🇹Roma, Lazio, Italy
Gruppo MultiMedica SpA - Ospedale San Giuseppe
🇮🇹Milan, Lombardia, Italy
A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
🇮🇹Catania, Sicilia, Italy
Azienda ospedaliero-universitaria Senese
🇮🇹Siena, Toscana, Italy
Azienda Ospedaliero Universitaria delle Marche
🇮🇹Ancona, Italy
Presidio Ospedaliero GB Morgagni L Pierantoni
🇮🇹Forlì, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Italy
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-Si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Incheon Gwang'yeogsi, Korea, Republic of
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
SMG - SNU Boramae Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Central de la Fuerza Aérea del Perú
🇵🇪Lima, Peru
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital Universitario de Bellvitge
🇪🇸L´Hospitalet de LLobregat, Barcelona, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Málaga, 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, Taiwan
E-DA hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan