RIN-PF-302 – Fibrotic Lung Disease

An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease

Study Population

Up to 1850 patients will be given inhaled Treprostinil four times a day using an ultrasonic nebulizer.

Eligible subjects must have:

participated in RIN-PF-301, RIN-PF-303, or RIN-PF-305, and had 1 of the following:

a. Remained on study drug and completed all scheduled study visits

b. Was enrolled in RIN-PF-301, RIN-PF-303, or RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.

Subject is excluded from this study if the participant is pregnant or lactating or enrollment in RIN-PF-302 would represent a risk to the subject’s overall health.

Study visits

Onsite visits at week 4 then every 12 weeks and monthly phone calls for up 6 years

Study visits will continue until inhaled treprostinil becomes commercially available for IPF or PPF or the study is discontinued by the Sponsor (whichever is sooner).

Study Requirements

Medication is taken via nebuliser 4 times/day

Dosing diary to record medication administration times

Questionnaires, ECG, Blood test (non-fasting), Spirometry, DLCO at select onsite visits

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT04905693