Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Idiopathic Pulmonary FibrosisInterstitial Lung Disease
Interventions
DRUG

Placebo

Placebo administered QID

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 (108)

220

Far Eastern Memorial Hospital, New Taipei City

1070

Hôpital Erasme, Anderlecht

1200

Cliniques Universitaires Saint-Luc, Brussels

2000

Sanatorio Parque - Consultorios Externos, Rosario

2020

Ziekenhuis Aan de Stroom, Antwerp

2050

Royal Prince Alfred Hospital, Missenden Road, Camperdown

2109

Macquarie University, Macquarie Park

2145

Westmead Hospital, Corner of Hawkesbury and Darcy Road, Westmead

2900

Gentofte Hospital - Lungemedicinsk forskning, Hellerup

3000

UZ Leuven, Leuven

3004

Alfred Health, Melbourne

Austin Health, Melbourne

3204

Respiratory Medicine, Hamilton

4000

Centro Integral de Medicina Respiratoria, 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

Prince Charles Hospital, Chermside

4101

Mater Misericordiae Ltd, South Brisbane

5000

Odense University Hospital - Department of Respiratory Medicine J., Odense C

5021

Sanatorio Allende S.A., Córdoba

5067

Respiratory Clinical Trials Pty Ltd, Kent Town

5500

Centro Médico INSARES, Mendoza

5530

CHU UCL Namur asbl - Site Godinne, Yvoir

5800

Instituto Médico Río Cuarto, Río Cuarto

5870

Cairns Hospital, Cairns

6009

Institute for Respiratory Health - Midland, Nedlands

Institute for Respiratory Health - Nedlands, Nedlands

7061

SMG - SNU Boramae Medical Center, Seoul

7600

Instituto Ave Pulmo - Fundación enfisema, Mar del Plata

8003

Hospital Nacional Adolfo Guevara Velasco, Wanchaq

8013

Canterbury Respiratory Research Group, Christchurch

8200

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

9300

AZORG vzw, Aalst

11217

Taipei Veterans General Hospital, Taipei

13015

APHM-Hôpital Nord, Marseille

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14033

Hopital Cote de Nacre, Caen

14080

Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas, Mexico City

15036

Clinica Ricardo Palma, Lima

15046

Hospital Central de la Fuerza Aerea Del Peru, Lima

15131

Hospital de Chancay y Servicios Basicos deSalud, Huaral

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

18014

Hospital Universitario Virgen de Las Nieves, Granada

20123

Ospedale S. Giuseppe Multimedica, Milan

21565

Gachon University Gil Medical Center, Incheon

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañon, Madrid

30120

Hospital Clinico Universitario Virgen de la Arrixaca, Murcia

31059

Hôpital Larrey, Toulouse

33011

Hospital Universitario Central de Asturias, Oviedo

34362

Lady Davis Carmel Medical Center, Haifa

35033

Hôpital Pontchaillou, Rennes

37044

CHRU Tours - Hôpital Bretonneau, Tours

38100

Hillel Yaffe Medical Center, Hadera

39008

Hospital Universitario Marques de Valdecilla, Santander

41124

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

44281

Meir Medical Center, Kfar Saba

45239

Universitätsmedezin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen

47121

Presidio Ospedaliero GB Morgagni L Pierantoni, Forlì

51092

CHU Reims - Hôpital Maison Blanche, Reims

52621

Sheba Medical Center - PPDS, Ramat Gan

53100

Azienda Ospedaliera Universitaria Senese, Siena

60126

Azienda Ospedaliero-Universitaria delle Marche, Ancona

64060

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

64239

Tel Aviv Sourasky Medical Center - PPDS, Tel Aviv

64460

"Hospital Universitario Dr. José Eleuterio González", Monterrey

74245

Klinik Löwenstein GmbH, Löwenstein

75015

Service de Pneumologie, Hôpital Européen Georges Pompídou (HEGP), Paris

75018

Hôpital Bichat, Paris

76000

Hôpital Charles Nicolle-1 Rue de Germont, Rouen

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

76100

Kaplan Medical Center, Rehovot

80054

CHU Amiens Picardie Site Sud - Service de Pneumologie, Amiens

80756

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

81377

LMU Klinikum der Universität, München

82445

E-DA hospital, Kaohsiung City

83022

RoMed Klinikum Rosenheim, Rosenheim

91120

Hadassah Medical Center - PPDS, Jerusalem

93000

Hôpital Avicenne, Bobigny

95123

"Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco", Catania

99437

Zentralklinik Bad Berka GmbH, Bad Berka

2520598

Oncocentro APYS, Viña del Mar

3109601

Rambam Medical Center - PPDS, Haifa

3465586

Centro de Investigacion del Maule SpA, Talca

4910000

Rabin Medical Center - PPDS, Petah Tikva

7500691

Instituto Nacional Torax, Santiago

7630000

Fundación Médica San Cristobal, Santiago

9103102

Shaare Zedek Medical Center, Jerusalem

C1027AAP

CINME S.A. - Centro de Investigaciones Metabolicas, Ciudad Autonoma de Buenos Aires

C1426ABP

Centro Medico Dra. De Salvo, Ciudad Autonoma de Buenos Aires

69677 Cedex

Groupement Hospitalier EST, Service de Pneumologie, Lyon

01640

Fachkrankenhaus Coswig, Coswig

00168

Fondazione Policlinico Universitario A Gemelli-Rome, Roma

00133

Fondazione PTV Policlinico Tor Vergata, Rome

6419 PC

Zuyderland Medisch Centrum, Heerlen

3015 GD

Erasmus MC, Rotterdam

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

05505

Asan Medical Center, Seoul

02841

Korea University Anam Hospital, Seoul

03312

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

06351

Samsung Medical Center - PPDS, Seoul

07120

Hospital Universitario Son Espases, Palma de Mallorca

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY