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Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Study Purpose
Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 40 Years and Over |
| Gender | All |
Inclusion Criteria:
1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ≥40 years of age, inclusive, at the time of signing informed consent. 3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy. 4. FVC ≥45% predicted at Screening. 5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted. 6. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening 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. 7. 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. 8. 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. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening. 3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy. 4. The subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours of any study-related efficacy assessments. 5. Use of any of the following medications: azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline; cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior to Baseline. 6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible. 8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline. 9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation. 10. 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) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible. 11. Life expectancy <6 months due to IPF or a concomitant illness. 12. Acute pulmonary embolism within 90 days prior to Baseline.Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05255991 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
United Therapeutics |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Peru, Spain, Taiwan |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease |
Study RIN-PF-303 is a multinational, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52. Efficacy assessments include spirometry (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 lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Arms
Placebo Comparator: Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
Experimental: Inhaled Treprostinil
Treprostinil for 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 up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
CINME S.A. - Centro de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP
Status
Recruiting
Address
Centro Medico Dra. De Salvo
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP
Status
Recruiting
Address
Instituto Ave Pulmo - Fundación enfisema
Mar del Plata, Buenos Aires, 7600
Status
Recruiting
Address
Instituto Médico Río Cuarto
Río Cuarto, Cordoba, 5800
Status
Recruiting
Address
Centro Integral de Medicina Respiratoria
San Miguel de Tucuman, Tucuman, 4000
Status
Recruiting
Address
Investigaciones en Patologías Respiratorias
San Miguel de Tucuman, Tucuman, 4000
Status
Recruiting
Address
Sanatorio Allende S.A.
Cordoba, , 5021
Status
Recruiting
Address
Centro Médico INSARES
Mendoza, , 5500
Status
Recruiting
Address
Royal Prince Alfred Hospital, Missenden Road
Camperdown, New South Wales, 2050
Status
Recruiting
Address
Macquarie University
Macquarie Park, New South Wales, 2109
Status
Recruiting
Address
Westmead Hospital, Corner of Hawkesbury and Darcy Road
Westmead, New South Wales, 2145
Status
Recruiting
Address
Cairns Hospital
Cairns, Queensland, 4870
Status
Recruiting
Address
Lung Research Qld
Chermside, Queensland, 4032
Status
Recruiting
Address
Prince Charles Hospital
Chermside, Queensland, 4032
Status
Recruiting
Address
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Respiratory Clinical Trials Pty Ltd
Kent Town, South Australia, 5067
Status
Recruiting
Address
Alfred Health
Melbourne, Victoria, 3004
Status
Recruiting
Address
Austin Health
Melbourne, Victoria, 3004
Status
Recruiting
Address
Institute for Respiratory Health - Midland
Nedlands, Western Australia, 6009
Status
Recruiting
Address
Institute for Respiratory Health - Nedlands
Nedlands, Western Australia, 6009
Status
Recruiting
Address
Hôpital Erasme
Anderlecht, Brussels, 1070
Status
Recruiting
Address
CHU UCL Namur asbl - Site Godinne
Yvoir, Namur, 5530
Status
Recruiting
Address
Onze-Lieve-Vrouwziekenhuis -Aalst
Aalst, , 9300
Status
Recruiting
Address
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Antwerpen, , 2020
Status
Recruiting
Address
Cliniques Universitaires Saint-Luc
Brussels, , 1200
Status
Recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Recruiting
Address
CHR de la Citadelle
Liège, , 4000
Status
Recruiting
Address
CHU de Liège
Liège, , 4000
Status
Recruiting
Address
Centro de Investigacion del Maule SpA
Talca, Maule, 3465586
Status
Recruiting
Address
Fundación Médica San Cristobal
Santiago, Region Metropolitana, 7630000
Status
Recruiting
Address
Instituto Nacional Torax
Santiago, Región Metropolitana, 7500691
Status
Recruiting
Address
Oncocentro APYS
Viña del Mar, Valparaiso, 2520598
Status
Recruiting
Address
Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
Aarhus N, , 8200
Status
Recruiting
Address
Gentofte Hospital - Lungemedicinsk forskning
Hellerup, , 2900
Status
Recruiting
Address
Odense University Hospital - Department of Respiratory Medicine J.
Odense C, , 5000
Status
Enrolling by invitation
Address
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033
Status
Recruiting
Address
Hôpital Avicenne
Bobigny, Seine-Saint Denis, 93000
Status
Recruiting
Address
CHU Amiens Picardie Site Sud - Service de Pneumologie
Amiens Cedex 1, , 80054
Status
Recruiting
Address
Hopital Cote de Nacre
Caen, , 14033
Status
Recruiting
Address
Groupement Hospitalier EST, Service de Pneumologie
Lyon, , 69677 Cedex
Status
Recruiting
Address
APHM-Hôpital Nord
Marseille, , 13015
Status
Recruiting
Address
Service de Pneumologie, Hôpital Européen Georges Pompídou (HEGP)
Paris, , 75015
Status
Recruiting
Address
Hôpital Bichat
Paris, , 75018
Status
Recruiting
Address
CHU Reims - Hôpital Maison Blanche
Reims Cedex, , 51092
Status
Recruiting
Address
Hôpital Charles Nicolle-1 Rue de Germont
Rouen, , 76000
Status
Recruiting
Address
Hôpital Larrey
Toulouse Cedex 9, , 31059
Status
Recruiting
Address
CHRU Tours - Hôpital Bretonneau
TOURS Cedex 9, , 37044
Status
Recruiting
Address
Klinik Löwenstein GmbH
Löwenstein, Baden-Württemberg, 74245
Status
Recruiting
Address
RoMed Klinikum Rosenheim
Rosenheim, Bayern, 83022
Status
Recruiting
Address
Universitätsmedezin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Nordrhein-Westfalen, 45239
Status
Recruiting
Address
Zentralklinik Bad Berka GmbH
Bad Berka, , 99437
Status
Recruiting
Address
Fachkrankenhaus Coswig
Coswig, , 01640
Status
Recruiting
Address
LMU Klinikum der Universität
München, , 81377
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv, HaDarom, 64239
Status
Recruiting
Address
Meir Medical Center
Kfar Sava, HaMerkaz, 44281
Status
Recruiting
Address
Kaplan Medical Center
Rehovot, HaMerkaz, 76100
Status
Recruiting
Address
Sheba Medical Center - PPDS
Ramat Gan, Tel-Aviv, 52621
Status
Recruiting
Address
Sheba Medical Center - PPDS
Ramat-Gan, Tel-Aviv, 52621
Status
Recruiting
Address
Shaare Zedek Medical Center
Jerusalem, Yerushalayim, 9103102
Status
Recruiting
Address
Hadassah Medical Center - PPDS
Jerusalem, Yerushalayim, 91120
Status
Recruiting
Address
Hillel Yaffe Medical Center
Hadera, , 38100
Status
Recruiting
Address
Rambam Medical Center - PPDS
Haifa, , 3109601
Status
Recruiting
Address
Lady Davis Carmel Medical Center
Haifa, , 34362
Status
Recruiting
Address
Rabin Medical Center - PPDS
Petah Tiqva, , 4910000
Status
Recruiting
Address
Presidio Ospedaliero GB Morgagni L Pierantoni
Forli, Emilia-Romagna, 47121
Status
Recruiting
Address
Ospedale S. Giuseppe Multimedica
Milano, Lombardia, 20123
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico-San Marco"
Catania, Sicilia, 95123
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Senese
Siena, Toscana, 53100
Status
Recruiting
Address
Azienda Ospedaliero-Universitaria delle Marche
Ancona, , 60126
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, , 41124
Status
Recruiting
Address
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, , 00168
Status
Recruiting
Address
Fondazione PTV Policlinico Tor Vergata
Rome, , 00133
Status
Recruiting
Address
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, 13496
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
Status
Recruiting
Address
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 05505
Status
Recruiting
Address
SMG - SNU Boramae Medical Center
Seoul, Seoul Teugbyeolsi, 7061
Status
Recruiting
Address
Gachon University Gil Medical Center
Incheon, , 21565
Status
Recruiting
Address
Korea University Anam Hospital
Seoul, , 02841
Status
Recruiting
Address
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, , 03312
Status
Recruiting
Address
Samsung Medical Center
Seoul, , 06351
Status
Recruiting
Address
Unidad de Investigación Clínica en Medicina, S.C.
Monterrey, Nuevo León, 64060
Status
Recruiting
Address
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Status
Recruiting
Address
Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas
Ciudad de México, , 14080
Status
Recruiting
Address
Zuyderland Medisch Centrum
Heerlen, Limburg, 6419 PC
Status
Recruiting
Address
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
Status
Recruiting
Address
Erasmus MC
Rotterdam, Zuid-Holland, 3015 GD
Status
Recruiting
Address
Canterbury Respiratory Research Group
Christchurch, Canterbury, 8013
Status
Recruiting
Address
Respiratory Medicine
Hamilton, Waikato, 3204
Status
Recruiting
Address
Hospital de Chancay y Servicios Basicos deSalud
Huaral, Lima, 15131
Status
Recruiting
Address
Clinica Ricardo Palma
Lima, , 15036
Status
Recruiting
Address
Hospital Central de la Fuerza Aerea Del Peru
Lima, , 15046
Status
Recruiting
Address
Hospital Universitario Central de Asturias
Oviedo, Asturias, 33011
Status
Recruiting
Address
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, 08907
Status
Recruiting
Address
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, 07120
Status
Recruiting
Address
Hospital Universitari Vall d'Hebron
Barcelona, , 08035
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital Universitario Virgen de Las Nieves
Granada, , 18014
Status
Recruiting
Address
Hospital Universitario de La Princesa
Madrid, , 28006
Status
Recruiting
Address
Hospital General Universitario Gregorio Marañon
Madrid, , 28007
Status
Recruiting
Address
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, , 30120
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , 15706
Status
Recruiting
Address
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung, Samin District, 80756
Status
Recruiting
Address
E-DA hospital
Kaohsiung, , 82445
Status
Recruiting
Address
Far Eastern Memorial Hospital
New Taipei City, , 220
Status
Recruiting
Address
Taipei Veterans General Hospital
Taipei, , 11217
