Phase 3 Randomized Study Evaluating Inhaled Treprostinil Versus Placebo for Progressive Pulmonary Fibrosis Treatment

What this Trial Is About

Researchers are studying inhaled treprostinil to assess its safety and effectiveness in people with progressive pulmonary fibrosis PPF. This Phase 3, multinational, randomized, double-blind, placebo-controlled trial will compare inhaled treprostinil to a placebo over one year. The study focuses on adults diagnosed with PPF who have shown lung fibrosis progression despite standard treatments. Participants will be randomly assigned to receive either inhaled treprostinil or a matching placebo using an ultrasonic nebulizer four times a day. The dose starts at 3 breaths per session and will be gradually increased to a target of 12 breaths per session or the highest tolerated dose. The treatment period includes six visits at weeks 4, 8, 16, 28, 40, and 52. Those completing the 52-week treatment may join an open-label extension study. During the study, participants will undergo lung function tests like forced vital capacity FVC and lung diffusion capacity DLCO, complete questionnaires about their lung disease, and have blood tests to measure biomarkers. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and electrocardiograms. The main measure is the change in lung function from the start to week 52, with additional assessments of clinical worsening, acute lung exacerbations, survival, and oxygen use.

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)