Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— TETON-OLE  

Official title:

An Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04905693
• Other study ID #: RIN-PF-302
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: September 6, 2022
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 792
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.

2. 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.

3. 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.

4. 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.

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Argentina	Centro Médico Dra. De Salvo	Ciudad Autónoma de Buenos Aires
Argentina	CINME S.A. - Centro de Investigaciones Metabólicas	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio Allende Cerro	Córdoba	Provincia De Córdoba
Argentina	Instituto Ave Pulmo - Fundación enfisema	Mar del Plata	Buenos Aires
Argentina	Centro Médico INSARES	Mendoza	Provincia De Mendoza
Argentina	Instituto Medico Río Cuarto	Rio Cuarto	Provincia De Córdoba
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Lung Research Qld	Chermside	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Macquarie University	Macquarie University	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	Mater Misericordiae Ltd	South Brisbane	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	ZNA Middelheim	Antwerpen
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	CHR de la Citadelle	Liège
Chile	Centro Respiratorio Integral Limitada	Quillota	Valparaiso
Chile	CEC Centro de Estudios Clínicos	Santiago	Metropolitana
Chile	Instituto Nacional del tórax	Santiago	Región Metropolitana
Chile	Centro de Investigación del Maule SpA	Talca	Maule
Denmark	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
France	Hospices Civils De Lyon - Université Hospital of Lyon	Bron
France	Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille	Marseille	Bouches-du-Rhône
France	Hôptial Bichat	Paris
France	Hopital Larrey	Toulouse	Haute-Garonne
France	Hôpital Bretonneau	Tours	Indre-et-Loire
Israel	Barzilai Medical Center	Ashkelon	HaDarom
Israel	Hillel Yaffe Medical Center	Hadera	Haifa
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Hadassah Medical Center - PPDS	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center - PPDS	Petah Tiqva
Israel	Sheba Medical Center - PPDS	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Israel	Tel Aviv Sourasky Medical Center - PPDS	Tel Aviv
Italy	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena	Emilia-Romagna
Italy	Fondazione PTV Policlinico Tor Vergata	Roma
Italy	Azienda ospedaliero-universitaria Senese	Siena	Toscana
Korea, Republic of	SMG - SNU Boramae Medical Center	Dongjak-Gu	Seoul Teugbyeolsi
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggido
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea - Eunpyeong St. Mary's Hospital	Seoul	Seoul Teugbyeolsi
Mexico	Unidad de Investigación Clínica en Medicina, S.C.	Monterrey	Nuevo León
Netherlands	Erasmus MC -Dr. Molewaterplein 40	Rotterdam	Zuid-Holland
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Universitario de Bellvitge	L´Hospitalet de LLobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Málaga
Spain	Hospital Clinico Universitario Virgen de La Arrixaca	Murcia
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Baleares
Spain	Hospital Universitario Marques de Valdecilla	Santander
Taiwan	E-DA hospital	Kaohsiung
Taiwan	Kaohsiung Medical University - Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Michigan Int Med Pulmonary and critical care	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare Atlanta	Atlanta	Georgia
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Lung Research Center, LLC	Chesterfield	Missouri
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Prisma Health Midlands	Columbia	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Clinical Trials Center of Middle Tennessee	Franklin	Arizona
United States	University of Florida Health at Shands	Gainesville	Florida
United States	PulmonIx, LLC	Greensboro	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	University Mississippi Medical Center	Jackson	Mississippi
United States	Ascension St. Vincent's	Jacksonville	Florida
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Pulmonary Disease Specialists, PA d/b/a PDS Research	Kissimmee	Florida
United States	StatCare Pulmonary Consultants, PLLC	Knoxville	Tennessee
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Louisville Healthcare Outpatient Center	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	A & A Research Consultants, LLC	McAllen	Texas
United States	Metroplex Pulmonary and Sleep Center PA	McKinney	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Intermountain Healthcare	Murray	Utah
United States	Northwell Health	New Hyde Park	New York
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	NewportNativeMD, Inc	Newport Beach	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Creighton University Clinical Research Office	Omaha	Nebraska
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Palmtree Clinical Research, Inc.	Palm Springs	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center - Norton Thoracic Institute	Phoenix	Arizona
United States	The Oregon Clinic	Portland	Oregon
United States	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia
United States	Mayo Clinic, Division of Pulmonary and Critical Care Medicine	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	Coastal Pulmonary & Critical Care PLC	Saint Petersburg	Florida
United States	University of Utah Health	Salt Lake City	Utah
United States	Adventist Healthcare White Oak Medical Center	Silver Spring	Maryland
United States	Stanford University School of Medicine	Stanford	California
United States	University of South Florida Health	Tampa	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	University of Arizona	Tucson	Arizona
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Chile,  Denmark,  France,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety and tolerability of inhaled treprostinil in subjects with IPF	Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs	Baseline to 6 years