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New hope for lung fibrosis patients: inhaled drug tested for long-term safety

NCT ID NCT04905693

Disease control Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of an inhaled medication called treprostinil for people with fibrotic lung diseases like idiopathic pulmonary fibrosis. About 1,850 adults who completed a prior related study will take the drug and be monitored for side effects. The goal is to see if the drug is safe to use over a longer period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 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: 1. Subject is pregnant or lactating. 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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis interstitial lung disease pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis Interstitial lung disease Progressive pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    193 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A & A Research Consultants, LLC

    McAllen, Texas, 78503, United States

  • A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"

    Catania, Sicily, 95123, Italy

  • AP-HP - Hopital Avicenne

    Bobigny, 93000, France

  • AP-HP - Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit

    Aarhus N, 8200, Denmark

  • Adventist Healthcare White Oak Medical Center

    Silver Spring, Maryland, 98374, United States

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna, 41124, Italy

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126, Italy

  • Azienda ospedaliero-universitaria Senese

    Siena, Tuscany, 53100, Italy

  • Banner University Medical Center-Phoenix

    Phoenix, Arizona, 85006, United States

  • Barzilai Medical Center

    Ashkelon, Southern District, 78278, Israel

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CEC Centro de Estudios Clínicos

    Santiago, Santiago Metropolitan, 7750495, Chile

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggido, 13496, South Korea

  • CHR de la Citadelle

    Liège, 4000, Belgium

  • CHU Amiens-Picardie

    Amiens, 80054, France

  • CHU Caen Normandie

    Caen, Calvados, 14000, France

  • CHU Rouen Hopital Charles Nicolle

    Rouen, Seine-Maritime, 76000, France

  • CHU UCL Namur - Site Godinne

    Yvoir, Namur, 5530, Belgium

  • CHU de Liège

    Liège, 4000, Belgium

  • CINME S.A. - Centro de Investigaciones Metabólicas

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP, Argentina

  • Cairns Hospital

    Cairns, Queensland, 5870, Australia

  • Canterbury Respiratory Research Group

    Christchurch, 8013, New Zealand

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803, United States

  • Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche

    Reims, 51092, France

  • Centre d'investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T7A1, Canada

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Centro Médico Dra. De Salvo

    Buenos Aires, C1426ABP, Argentina

  • Centro Médico INSARES

    Mendoza, Mendoza Province, 5500, Argentina

  • Centro Respiratorio Integral Limitada

    Quillota, Valparaiso, 2260000, Chile

  • Centro de Investigación del Maule SpA

    Talca, Maule Region, 3481349, Chile

  • Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)

    Monterrey, Nuevo León, 64460, Mexico

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Clinica Ricardo Palma

    Lima, 15036, Peru

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Clinical Trials Center of Middle Tennessee

    Franklin, Arizona, 37067, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Coastal Pulmonary & Critical Care PLC

    St. Petersburg, Florida, 33704, United States

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Corewell Health William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Creighton University Clinical Research Office

    Omaha, Nebraska, 68124, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Dynamic Drug Advancement Limited

    Ajax, Ontario, L1S2J5, Canada

  • E-DA hospital

    Kaohsiung City, 82445, Taiwan

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus MC -Dr. Molewaterplein 40

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Far Eastern Memorial Hospital

    New Taipei City, 22060, Taiwan

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 00133, Italy

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Rome, Lazio, 00168, Italy

  • Fundación Médica San Cristobal

    Santiago, Santiago Metropolitan, 76302266, Chile

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi, 21565, South Korea

  • Gentofte Hospital - Lungemedicinsk forskningsafdeling

    Hellerup, 2900, Denmark

  • Gruppo MultiMedica SpA - Ospedale San Giuseppe

    Milan, Lombardy, 20123, Italy

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120, Israel

  • Hillel Yaffe Medical Center

    Hadera, Haifa District, 38100, Israel

  • Hopital Larrey

    Toulouse, Haute-Garonne, 31059, France

  • Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille

    Marseille, Bouches-du-Rhône, 13015, France

  • Hospices Civils De Lyon - Université Hospital of Lyon

    Bron, 69500, France

  • Hospital Central de la Fuerza Aérea del Perú

    Lima, 15046, Peru

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de La Arrixaca

    Murcia, 30120, Spain

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco

    Cusco, 08002, Peru

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044, France

  • Hôpital Erasme

    Anderlecht, Brussels Capital, 1070, Belgium

  • Hôpital Pontchaillou

    Rennes, 35000, France

  • Hôptial Bichat

    Paris, 75018, France

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, G1V 4G5, Canada

  • Instituto Ave Pulmo - Fundación enfisema

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Instituto Medico Río Cuarto

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

    Mexico City, 14080, Mexico

  • Instituto Nacional del tórax

    Santiago, Santiago Metropolitan, 7500691, Chile

  • Intermountain Healthcare

    Murray, Utah, 84107, United States

  • Investigaciones en Patologías Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224, United States

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaplan Medical Center

    Rehovot, Central District, 76100, Israel

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • LMU Klinikum der Universität München

    München, Bavaria, 81377, Germany

  • LSU Health Science Center Shreveport

    Shreveport, Louisiana, 71103, United States

  • Lady Davis Carmel Medical Center

    Haifa, 34362, Israel

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Lung Research Qld

    Chermside, Queensland, 4032, Australia

  • Macquarie University

    Macquarie Park, New South Wales, 2109, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101, Australia

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Division of Pulmonary and Critical Care Medicine

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center

    Kfar Saba, 4428100, Israel

  • Metroplex Pulmonary and Sleep Center PA

    McKinney, Texas, 75069, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • NewportNativeMD, Inc

    Newport Beach, California, 92663, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202, United States

  • Odense University Hospital - Department of Respiratory Medicine

    Odense C, 5000, Denmark

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262, United States

  • Penn State Milton S.Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Healthcare Atlanta

    Atlanta, Georgia, 30309, United States

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, 47121, Italy

  • Prisma Health Midlands

    Columbia, South Carolina, 29203, United States

  • Prüfstelle der GWT am Fachkrankenhaus Coswig

    Coswig, Saxony, 1640, Germany

  • PulmonIx, LLC

    Greensboro, North Carolina, 27403, United States

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

  • Pulmonary Disease Specialists, PA d/b/a PDS Research

    Kissimmee, Florida, 34741, United States

  • Rabin Medical Center - PPDS

    Petah Tikva, 49100, Israel

  • Renovatio Clinical

    The Woodlands, Texas, 77380, United States

  • RoMed Klinikum Rosenheim

    Rosenheim, Bavaria, 83022, Germany

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin

    Löwenstein, Baden-Wurttemberg, 74245, Germany

  • SMG - SNU Boramae Medical Center

    Seoul, Seoul Teugbyeolsi, 07061, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sanatorio Allende Cerro

    Córdoba, Córdoba Province, 5021, Argentina

  • Sanatorio Parque de Rosario - Consultorios Externos

    Rosario, Santa Fe Province, 2000, Argentina

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 91031, Israel

  • Sheba Medical Center - PPDS

    Ramat Gan, Tel Aviv, 52621, Israel

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

  • St. Joseph's Hospital and Medical Center - Norton Thoracic Institute

    Phoenix, Arizona, 85013, United States

  • St.Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • StatCare Pulmonary Consultants, PLLC

    Knoxville, Tennessee, 37919, United States

  • Stony Brook Advanced Specialty Care

    Commack, New York, 11725, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center - PPDS

    Tel Aviv, 64239, Israel

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital

    Seoul, Seoul Teugbyeolsi, 03312, South Korea

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201, United States

  • The Oregon Clinic

    Portland, Oregon, 97220, United States

  • The Prince Charles Hospital

    Chermside, Queensland, 4032, Australia

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • The University of Texas Health Science Center at Houston, McGovern Medical School

    Houston, Texas, 77030, United States

  • Thomas Jefferson,Hospital University

    Philadelphia, Pennsylvania, 19107, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112, United States

  • UC Davis Health Medical Center

    Sacramento, California, 95817, United States

  • UC San Diego Health

    La Jolla, California, 92037, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Unidad de Investigación Clínica en Medicina, S.C.

    Monterrey, Nuevo León, 64718, Mexico

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792, United States

  • University Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45227, United States

  • University of Florida Health at Shands

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Louisville Healthcare Outpatient Center

    Louisville, Kentucky, 40202, United States

  • University of Michigan Int Med Pulmonary and critical care

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of South Florida Health

    Tampa, Florida, 33606, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8550, United States

  • University of Utah Health

    Salt Lake City, Utah, 84108, United States

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22903, United States

  • Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, North Rhine-Westphalia, 45239, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204, United States

  • Waikato Hospital

    Hamilton, Waikato Region, 3204, New Zealand

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical Center

    New York, New York, 10021, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Zentralklinik Bad Berka GmbH Klinik für Pneumologie

    Bad Berka, Thuringia, 99437, Germany

  • Ziekenhuis Aan de Stroom

    Antwerp, 2020, Belgium

  • Zuyderland Medisch Centrum - Heerlen

    Heerlen, Limburg, 6419 PC, Netherlands

  • vzw AZORG - Aalst - Moorselbaan

    Aalst, 9300, Belgium

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