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
- Barcelona, Granada, L'Hospitalet de Llobregat, Madrid, Málaga, Murcia, Oviedo, Palma de Mallorca, Santander, and Santiago de Compostela, SpainSee the 13 sites
- Phase
- Phase 3
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainNo longer taking part
- Hospital Universitario Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital Universitario Virgen de las NievesGranada, SpainNo longer taking part
- Hospital Universitario de BellvitgeL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital Clínico San CarlosMadrid, SpainNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
- Hospital Universitario de la PrincesaMadrid, SpainNo longer taking part
- Hospital Universitario Virgen de la VictoriaMálaga, SpainNo longer taking part
- Hospital Clínico Universitario Virgen de la ArrixacaMurcia, SpainNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpainNo longer taking part
- Hospital Universitario Son EspasesPalma de Mallorca, SpainNo longer taking part
- Hospital Universitario Marqués de ValdecillaSantander, SpainNo longer taking part
- Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, SpainNo 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.