Tests long-term safety of inhaled treprostinil in people with lung scarring
Tests inhaled treprostinil's long-term safety in adults with progressive pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
Key facts
- Where
- Buenos Aires, Ciudad Autónoma de Buenos Aires, Córdoba, Mar del Plata, Mendoza, Río Cuarto, Rosario, and San Miguel de Tucumán, ArgentinaSee the 9 sites
- Phase
- Phase 3
Where in Argentina
- Centro Médico Dra de SalvoBuenos Aires, ArgentinaNo longer taking part
- CINME S.A. - Centro de Investigaciones MetabólicasCiudad Autónoma de Buenos Aires, ArgentinaNo longer taking part
- Sanatorio Allende CerroCórdoba, ArgentinaNo longer taking part
- Instituto Ave Pulmo-Fundacion EnfisemaMar del Plata, ArgentinaNo longer taking part
- Centro Médico INSARESMendoza, ArgentinaNo longer taking part
- Instituto Médico Río CuartoRío Cuarto, ArgentinaNo longer taking part
- Sanatorio Parque de Rosario - Consultorios ExternosRosario, ArgentinaNo longer taking part
- Centro Integral de Medicina Respiratoria - CIMERSan Miguel de Tucumán, ArgentinaNo longer taking part
- Investigaciones en Patologias RespiratoriasSan Miguel de Tucumán, ArgentinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- United Therapeutics
- Trial code
- NCT04905693
- Record updated
- 19 October 2026
- Original description
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.Read full original descriptionShow less
An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
Inclusion: Subject gives voluntary informed consent to participate in the study; 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; 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; 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; 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: 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; Subject is pregnant or lactating; In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.