Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

1,850

Participants

Timeline

Start Date

September 6, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Idiopathic Pulmonary FibrosisInterstitial Lung DiseaseProgressive Pulmonary Fibrosis
Interventions
DRUG

Inhaled Treprostinil

Inhaled Treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Trial Locations (187)

1070

Hôpital Erasme, Anderlecht

1200

Cliniques Universitaires Saint-Luc, Brussels

1640

Prüfstelle der GWT am Fachkrankenhaus Coswig, Coswig

2000

Sanatorio Parque de Rosario - Consultorios Externos, Rosario

2020

Ziekenhuis Aan de Stroom, Antwerp

2050

Royal Prince Alfred Hospital, Camperdown

2109

Macquarie University, Macquarie Park

2145

Westmead Hospital, Westmead

2900

Gentofte Hospital - Lungemedicinsk forskningsafdeling, Hellerup

3000

UZ Leuven, Leuven

3004

Alfred Health, Melbourne

3204

Waikato Hospital, Hamilton

4000

Centro Integral de Medicina Respiratoria (CIMER), San Miguel de Tucumán

Investigaciones en Patologías Respiratorias, San Miguel de Tucumán

CHR de la Citadelle, Liège

CHU de Liège, Liège

4032

Lung Research Qld, Chermside

The Prince Charles Hospital, Chermside

4101

Mater Misericordiae Ltd, South Brisbane

5000

Odense University Hospital - Department of Respiratory Medicine, Odense C

5021

Sanatorio Allende Cerro, Córdoba

5500

Centro Médico INSARES, Mendoza

5530

CHU UCL Namur - Site Godinne, Yvoir

5800

Instituto Medico Río Cuarto, Río Cuarto

5870

Cairns Hospital, Cairns

7600

Instituto Ave Pulmo - Fundación enfisema, Mar del Plata

8013

Canterbury Respiratory Research Group, Christchurch

8200

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

9300

vzw AZORG - Aalst - Moorselbaan, Aalst

10467

Montefiore Medical Center, The Bronx

11042

Northwell Health, New Hyde Park

11217

Taipei Veterans General Hospital, Taipei

11725

Stony Brook Advanced Specialty Care, Commack

13015

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

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14000

CHU Caen Normandie, Caen

14080

Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas, Mexico City

14642

University of Rochester Medical Center, Rochester

15036

Clinica Ricardo Palma, Lima

15046

Hospital Central de la Fuerza Aérea del Perú, Lima

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

17033

Penn State Milton S.Hershey Medical Center, Hershey

18014

Hospital Universitario Virgen de Las Nieves, Granada

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson,Hospital University, Philadelphia

19140

Temple University Hospital, Philadelphia

20123

Gruppo MultiMedica SpA - Ospedale San Giuseppe, Milan

21224

Johns Hopkins Asthma and Allergy Center, Baltimore

21565

Gachon University Gil Medical Center, Incheon

22042

Inova Fairfax Hospital, Falls Church

22060

Far Eastern Memorial Hospital, New Taipei City

22903

University of Virginia Health Systems, Charlottesville

23230

Pulmonary Associates of Richmond, Inc., Richmond

27103

Southeastern Research Center, Winston-Salem

27403

PulmonIx, LLC, Greensboro

27834

East Carolina University, Greenville

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Hospital Clinico San Carlos, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

29203

Prisma Health Midlands, Columbia

29425

Medical University of South Carolina, Charleston

29732

Clinical Research of Rock Hill, Rock Hill

30120

Hospital Clinico Universitario Virgen de La Arrixaca, Murcia

30309

Piedmont Healthcare Atlanta, Atlanta

30322

Emory University, Atlanta

31059

Hopital Larrey, Toulouse

32204

Ascension St. Vincent's, Jacksonville

32209

University of Florida, Jacksonville

32224

Mayo Clinic Florida, Jacksonville

32610

University of Florida Health at Shands, Gainesville

32803

Central Florida Pulmonary Group, PA, Orlando

33011

Hospital Universitario Central de Asturias, Oviedo

33331

Cleveland Clinic Florida, Weston

33606

University of South Florida Health, Tampa

33704

Coastal Pulmonary & Critical Care PLC, St. Petersburg

34362

Lady Davis Carmel Medical Center, Haifa

34741

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

35000

Hôpital Pontchaillou, Rennes

35233

The University of Alabama at Birmingham, Birmingham

37044

Hôpital Bretonneau, Tours

37067

Clinical Trials Center of Middle Tennessee, Franklin

37204

Vanderbilt University Medical Center, Nashville

37919

StatCare Pulmonary Consultants, PLLC, Knoxville

38100

Hillel Yaffe Medical Center, Hadera

39008

Hospital Universitario Marques de Valdecilla, Santander

39216

University Mississippi Medical Center, Jackson

40202

Norton Pulmonary Specialists, Louisville

University of Louisville Healthcare Outpatient Center, Louisville

41124

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

43201

The Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic, Cleveland

45227

University of Cincinnati Medical Center, Cincinnati

45239

Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen

46250

Community Health Network, Indianapolis

47121

Presidio Ospedaliero GB Morgagni L Pierantoni, Forlì

48073

Corewell Health William Beaumont Hospital, Royal Oak

48109

University of Michigan Int Med Pulmonary and critical care, Ann Arbor

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center - PPDS, Petah Tikva

51092

Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche, Reims

52621

Sheba Medical Center - PPDS, Ramat Gan

53100

Azienda ospedaliero-universitaria Senese, Siena

53226

Medical College of Wisconsin, Milwaukee

53792

University Hospital and UW Health Clinics, Madison

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Division of Pulmonary and Critical Care Medicine, Rochester

60126

Azienda Ospedaliero Universitaria delle Marche, Ancona

60153

Loyola University Medical Center, Maywood

60611

Northwestern Memorial Hospital, Chicago

63017

The Lung Research Center, LLC, Chesterfield

63110

Washington University School of Medicine, St Louis

64239

Tel Aviv Sourasky Medical Center - PPDS, Tel Aviv

64460

Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP), Monterrey

64718

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

66160

University of Kansas Medical Center, Kansas City

68124

Creighton University Clinical Research Office, Omaha

69500

Hospices Civils De Lyon - Université Hospital of Lyon, Bron

70112

Tulane University Medical Center, New Orleans

71103

LSU Health Science Center Shreveport, Shreveport

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74245

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

75015

AP-HP - Hôpital Européen Georges Pompidou, Paris

75018

Hôptial Bichat, Paris

75069

Metroplex Pulmonary and Sleep Center PA, McKinney

75246

Baylor University Medical Center, Dallas

76000

CHU Rouen Hopital Charles Nicolle, Rouen

76100

Kaplan Medical Center, Rehovot

77030

Baylor College of Medicine, Houston

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

The University of Texas Health Science Center at Houston, Houston

77380

Renovatio Clinical, The Woodlands

78278

Barzilai Medical Center, Ashkelon

78503

A & A Research Consultants, LLC, McAllen

80054

CHU Amiens-Picardie, Amiens

80206

National Jewish Health, Denver

80756

Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung City

81377

LMU Klinikum der Universität München, München

82445

E-DA hospital, Kaohsiung City

83022

RoMed Klinikum Rosenheim, Rosenheim

84107

Intermountain Healthcare, Murray

84108

University of Utah Health, Salt Lake City

85006

Banner University Medical Center-Phoenix, Phoenix

85013

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

85724

University of Arizona, Tucson

87106

University of New Mexico Health Sciences Center, Albuquerque

90095

David Geffen School of Medicine at UCLA, Los Angeles

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center - PPDS, Jerusalem

92262

Palmtree Clinical Research, Inc., Palm Springs

92663

NewportNativeMD, Inc, Newport Beach

93000

AP-HP - Hopital Avicenne, Bobigny

94305

Stanford University School of Medicine, Stanford

95123

"A.O.U. Policlinico Vittorio Emanuele presidio G.Rodolico", Catania

95817

UC Davis Health Medical Center, Sacramento

97220

The Oregon Clinic, Portland

98374

Adventist Healthcare White Oak Medical Center, Silver Spring

99437

Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Bad Berka

2260000

Centro Respiratorio Integral Limitada, Quillota

3481349

Centro de Investigación del Maule SpA, Talca

4428100

Meir Medical Center, Kfar Saba

7500691

Instituto Nacional del tórax, Santiago

7750495

CEC Centro de Estudios Clínicos, Santiago

76302266

Fundación Médica San Cristobal, Santiago

02111

Tufts Medical Center, Boston

02115

Brigham and Women's Hospital, Boston

75390-8550

University of Texas Southwestern Medical Center, Dallas

C1027AAP

CINME S.A. - Centro de Investigaciones Metabólicas, Ciudad Autónoma de Buenos Aires

C1426ABP

Centro Médico Dra. De Salvo, Buenos Aires

V6Z 1Y6

St.Paul's Hospital, Vancouver

L1S2J5

Dynamic Drug Advancement Limited, Ajax

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

G8T7A1

Centre d'investigation Clinique Mauricie, Trois-Rivières

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Québec

00168

Fondazione Policlinico Universitario A Gemelli-Rome, Rome

00133

Fondazione PTV Policlinico Tor Vergata, Roma

6419 PC

Zuyderland Medisch Centrum - Heerlen, Heerlen

3015 GD

Erasmus MC -Dr. Molewaterplein 40, Rotterdam

08002

Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco, Cusco

03312

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

07061

SMG - SNU Boramae Medical Center, Seoul

06351

Samsung Medical Center, Seoul

07120

Hospital Universitario Son Espases, Palma de Mallorca

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY