Phase 3 OLE Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease
Research type
Research Study
Full title
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease
IRAS ID
1013404
Contact name
Jeff Sigman
Contact email
Sponsor organisation
United Therapeutics Corporation
Clinicaltrials.gov Identifier
Research summary
Progressive Pulmonary Fibrosis (PPF) is a lung disease that occurs when lung tissue becomes progressively damaged and scarred.
This thickened, stiff lung tissue makes it more difficult for the lungs to work properly, which causes shortness of breath. This is Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease, sponsored by United Therapeutics Corporation . The purpose of this study is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with PPF. All eligible participants who completed RIN-PF-305 (called the “parent study”) can roll over to RIN-PF-302. Treprostinil is given by breathing in the medicine into participants lungs using a machine called a nebuliser (inhaling device). Inhaled treprostinil is approved in certain countries for the treatment of certain types of pulmonary hypertension (a disease where damage to the blood vessels in the lungs makes it hard to breathe, including one type of this disease that is caused by pulmonary fibrosis). Inhaled treprostinil has not been approved for the treatment of PPF. Up to 1850 people will participate in this study from about 250 medical centres globally. During the Week 52 Study Visit/ End of Study Visit in the parent study, eligible participants will be given the opportunity to participate in this OLE study, buy signing the Participant Information sheet and consent form. The procedures performed at the Week 52 Study Visit/End of Study Visit in the parent study will also be the entry visit procedures for this OLE study. Participants will receive their firs dose of the study drug. At each Study Visit (Week 4, Week 12, then Follow-Up Visits – Every 12 Weeks) and at Week 48 Follow-up Visit Only participants will complete the study tests and procedures to check the participant’s health and the effects of the study drug.REC name
London - Hampstead Research Ethics Committee
REC reference
26/LO/0380
Date of REC Opinion
16 Jun 2026
REC opinion
Further Information Favourable Opinion