NCT04905693

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,850 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). 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 PPF, 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 or interstitial lung disease (ILD), 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 with IPF rolling over from Study RIN-PF-301 and up to 24 eligible subjects with PPF rolling over from Study RIN-PF-305 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Conditions

• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Progressive Pulmonary Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-05-28
• Last updated: 2026-03-31

Locations

193 sites across 18 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study