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Study on Long-Term Safety of Inhaled Treprostinil for Patients with Fibrotic Lung Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Fibrotic Lung Disease, which involves scarring of the lung tissue that can make breathing difficult. The treatment being tested in this study is called Treprostinil, which is administered as a nebuliser solution. A nebuliser is a device that turns liquid medicine into a mist, making it easier to inhale directly into the lungs. The purpose of this study is to evaluate the long-term safety and tolerability of inhaled Treprostinil in individuals with this lung condition.

Participants in the study will use the Treprostinil nebuliser solution with a device known as the TD-300/A (TD-300), which is part of the Tyvaso Inhalation System. This system includes nebulisers and necessary accessories to help deliver the medication effectively. The study will observe participants over a period to monitor how well they tolerate the treatment and to gather information on any potential side effects.

Throughout the study, researchers will assess various health parameters, such as lung function and overall survival, to understand the effects of continued long-term therapy with Treprostinil. The study aims to provide valuable insights into the treatment's impact on the progression of Fibrotic Lung Disease and its potential benefits for patients living with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the study

    Upon joining the study, the participant will begin by providing informed consent, confirming their understanding and agreement to participate.

    A urine pregnancy test will be conducted for women of childbearing potential to confirm non-pregnancy.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's current health status. This includes reviewing medical history and conducting necessary tests to establish a baseline for the study.

  3. Step 3

    Medication administration

    Participants will begin treatment with Treprostinil, administered as a nebulizer solution for inhalation. The dosage and frequency will be determined by the study protocol and adjusted as necessary based on individual response and tolerability.

  4. Step 4

    Regular follow-up visits

    Participants will attend regular follow-up visits to monitor the effects of the medication. These visits will include assessments of lung function, overall health, and any side effects experienced.

    Vital signs, including oxygen levels, will be checked, and additional tests such as electrocardiograms (ECGs) may be performed.

  5. Step 5

    Long-term monitoring

    The study aims to evaluate the long-term safety and tolerability of inhaled Treprostinil. Participants will be monitored for changes in lung function, time to clinical worsening, and overall survival.

    Safety will be assessed through the review of adverse events, laboratory parameters, and other clinical evaluations.

  6. Step 6

    Completion of study

    The study is estimated to conclude by May 31, 2027. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

5 criteria

  • The patient must give their voluntary informed consent to join the study. This means they agree to participate after being fully informed about the study.
  • The patient must have participated in one of the previous studies: RIN-PF-301, RIN-PF-303, or RIN-PF-305, and either completed all scheduled visits or was part of the study when it was stopped for reasons other than safety.
  • Women who can have children must not be pregnant, as confirmed by a urine pregnancy test, and must not be breastfeeding. They must agree to either not have intercourse or use two highly effective forms of birth control during the study and for at least 30 days after stopping the study drug. Birth control methods can include hormonal contraceptives (like pills or injections) and barrier methods (like condoms or diaphragms) used with a spermicide. Women who are unable to have children or are postmenopausal do not need to follow these requirements.
  • Men with a partner who can have children must agree to use a condom during treatment and for at least 48 hours after stopping the study drug.
  • The patient must be able to communicate well with the study team and be considered reliable, willing, and likely to follow the study requirements, including attending all study visits.

Who cannot join the trial?

5 criteria

  • Patients with other types of lung diseases that are not related to fibrosis cannot participate.
  • Individuals who have not been diagnosed with either IPF (Idiopathic Pulmonary Fibrosis) or PPF (Progressive Pulmonary Fibrosis) are excluded.
  • Participants who are not within the specified age range for the study are not eligible.
  • People who are unable to follow the study procedures or take the study medication as required will be excluded.
  • Individuals who are part of a vulnerable population, which means they might have difficulty giving informed consent or understanding the study, cannot participate.
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Investigated drugs

Treprostinil is a medication used in this clinical trial to help manage fibrotic lung diseases. It is administered through inhalation, which means it is breathed directly into the lungs. The main goal of using this medication in the trial is to assess its long-term safety and how well patients can tolerate it. Treprostinil works by helping to improve blood flow in the lungs, which can help reduce symptoms and improve breathing in patients with conditions like idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

What is already known about the treatment

Treprostinil – Treprostinil is administered through inhalation, allowing the medication to directly reach the lungs. It is currently being studied in clinical trials for its safety and tolerability in treating fibrotic lung diseases, such as idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The main therapeutic indication for treprostinil is to improve lung function and alleviate symptoms associated with these conditions. At the molecular level, treprostinil works by dilating blood vessels in the lungs, reducing blood pressure, and improving blood flow. It is classified pharmacologically as a prostacyclin analog, which helps to relax and widen blood vessels.

Investigated diseases

Fibrotic Lung Disease – This condition involves the thickening and scarring of lung tissue, which can lead to a gradual decline in lung function. The disease often starts with symptoms like shortness of breath and a persistent dry cough. Over time, the scarring can make it increasingly difficult for the lungs to transfer oxygen into the bloodstream. As the disease progresses, individuals may experience fatigue, unexplained weight loss, and clubbing of the fingers. The exact cause of the fibrosis can vary, and in some cases, it may be linked to environmental factors or other underlying health conditions. The progression of the disease can vary significantly from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504471-25-00Protocol codeRIN-PF-302Estimated enrolment1 843 patientsSponsorUnited Therapeutics Corp.

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