RIN-PF-305 – Progressive Pulmonary Fibrosis

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with PPF treated with inhaled treprostinil over a 52-week period. (TETON-PPF)

Who can take part?

You may be able to take part if you have progressive pulmonary fibrosis (PPF), a condition where the lungs become scarred over time, making it harder to breathe.

You may be eligible if you:

• Are 18 years of age or older
• Have been diagnosed with PPF (not idiopathic pulmonary fibrosis)
• Meet certain lung function criteria based on breathing tests and scans

You may be able to take part whether or not you are currently taking medications such as nintedanib or pirfenidone.

You would not be eligible if:

• Your lung condition is mainly related to airway obstruction
• You require high levels of oxygen at rest
• You are pregnant or breastfeeding

What is involved?

This study is looking at whether inhaled treprostinil may help people with PPF.

• Study duration: Approximately 12 months
• Clinic visits: 9 visits during the study
• Phone calls:
• • Weekly during the first 4 months
  • Then monthly until the end of the study

The study includes:

• A screening period (up to 6 weeks)
• A 52-week treatment period
• An end-of-study visit

What will I need to do?

If you take part, you will be asked to:

• Take the study medication using a nebuliser four times a day
• Keep a diary to record when you take your medication
• Attend clinic visits for tests, which may include:
• • Questionnaires about your health
  • A heart tracing (ECG)
  • Blood tests
  • Breathing tests

You will also have regular phone contact with the study team throughout the study.

After the study

If you complete this study, you may be eligible to take part in a longer-term extension study (RIN‑PF‑302).

More information

• ClinicalTrials.gov – RIN‑PF‑305 Study
• ClinicalTrials.gov – RIN‑PF‑302 Extension Study