TETON-PPF
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)
IRAS ID
1011078
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 a Phase 3, randomised, double-blind, placebo-controlled, multinational, efficacy and safety study sponsored by United Therapeutics Corporation to assess participants with PPF when treated with inhaled treprostinil over a 52-week period. This study will look at changes in participants breathing tests, also called lung function tests. Treprostinil is given by breathing in the medicine into participants lungs using a machine called a nebuliser (inhaling device). The purpose of this study is to see how well a drug called inhaled treprostinil works to help people with PPF improve their lung function, to gather information on how safe it is and to and to see if participants are able to administer treprostinil on their own with the nebuliser (TD 300/A 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.
Approximately 698 participants will be randomly assigned to study drug at approximately 150 study sites globally.
The study has two periods. During the study entry period, which lasts about 6 weeks, it will be determined if participants are eligible for the study. If eligible, participants will be randomly assigned 1:1 to inhaled treprostinil or placebo and will receive study drug through the 52-week treatment period. During the treatment period, participants will complete the study tests and procedures to check the participant’s health and the effects of the study drug.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0064
Date of REC Opinion
9 Jun 2025
REC opinion
Further Information Favourable Opinion