Inhaled Treprostinil for Pulmonary Fibrosis

(TETON-OLE Trial)

Recruiting at170 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: United Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

Research Team

Eligibility Criteria

This trial is for adults with idiopathic pulmonary fibrosis who previously participated in related studies (RIN-PF-301 or RIN-PF-303) and completed them or were active when the study ended. Participants must use effective contraception if of childbearing potential, be non-pregnant, non-lactating, reliable, and able to follow the study plan.

Inclusion Criteria

I will use a condom during treatment and for 48 hours after stopping the study drug.

You were in a previous study and completed all the visits or were still in the study when it was stopped by the company.

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 Criteria

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.

Treatment Details

Interventions

• Inhaled Treprostinil (Prostacyclin Analogue)
• Treprostinil Ultrasonic Nebulizer (Device)

Trial Overview The focus of this extension study is on assessing the long-term safety and tolerability of an inhaled medication called treprostinil using a nebulizer for patients with idiopathic pulmonary fibrosis.

Participant Groups

Group I: Inhaled Treprostinil Experimental Treatment 2 Interventions

Treprostinil inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated to a target of 15 breaths QID or until the subject reaches their maximum clinically tolerated dose.

Who Is Running the Clinical Trial?

United Therapeutics

Lead Sponsor

Trials

112

Recruited

14,500+

Dr. Martine Rothblatt

United Therapeutics

Chief Executive Officer since 1996

PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA

Dr. Michael Benkowitz

United Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School