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Study on the Effects of Inhaled Treprostinil for Patients with Idiopathic Pulmonary Fibrosis

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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 the effects of a medication called Treprostinil on a lung disease known as Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred over time, making it difficult to breathe. The study aims to evaluate how effective and safe inhaled Treprostinil is for people with this condition. Participants in the study will receive either the Treprostinil nebuliser solution or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if inhaled Treprostinil can improve lung function over a period of 52 weeks. Participants will use a device called a nebuliser to inhale the medication. This device turns the liquid medication into a mist that can be easily inhaled into the lungs. The study will monitor changes in lung function and other health outcomes over the course of the year.

Throughout the study, participants will have regular check-ups to assess their lung function and overall health. The main goal is to see if there is an improvement in lung capacity, which is measured by a test called Forced Vital Capacity (FVC). The study will also look at other factors such as the time it takes for the disease to worsen, any hospitalizations due to breathing problems, and overall survival rates. This research is important for understanding how Treprostinil might help people with IPF manage their symptoms and improve their quality of life.

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

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. The participant must provide informed consent to participate.

    Eligibility is confirmed based on specific criteria, including age, diagnosis of idiopathic pulmonary fibrosis (IPF), and lung function tests.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish baseline health status. This includes lung function tests to measure forced vital capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

    Participants on certain medications for IPF, such as pirfenidone or nintedanib, must be on a stable dose for at least 30 days before this assessment.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either the inhaled treprostinil or a placebo. The treatment is administered via a nebulizer, which turns the liquid medication into a mist to be inhaled.

    The dosage and frequency of administration are determined by the study protocol and are consistent throughout the trial duration.

  4. Step 4

    Ongoing assessments

    Regular follow-up visits are scheduled to monitor the participant's health and response to the treatment. These visits include repeated lung function tests and other assessments as required by the study protocol.

    Participants are monitored for any side effects or changes in their condition.

  5. Step 5

    End of treatment

    The treatment phase lasts until Week 52. At the end of this period, a final assessment is conducted to evaluate the change in lung function and overall health status.

    The primary endpoint is the change in absolute FVC from baseline to Week 52.

  6. Step 6

    Post-study follow-up

    After completing the treatment phase, participants may be asked to attend additional follow-up visits to monitor long-term effects and overall survival.

    The study aims to gather data on time to clinical worsening, time to first acute exacerbation of IPF, and changes in quality of life and lung function.

Who can join the trial?

8 criteria

  • The person must agree to participate in the study by giving their voluntary informed consent.
  • The person must be 40 years of age or older at the time of signing the consent.
  • The person must have a diagnosis of **Idiopathic Pulmonary Fibrosis (IPF)**, confirmed by specific medical guidelines and tests.
  • The person must have a **Forced Vital Capacity (FVC)** of 45% or more, as predicted during screening. FVC is a measure of lung function.
  • If the person is taking medications called **pirfenidone** or **nintedanib**, they must be on a stable dose for at least 30 days before starting the study. They cannot take both medications at the same time.
  • Women who can have children must not be pregnant or breastfeeding. They must either not have intercourse or use two effective forms of birth control during the study and for 30 days after stopping the study drug.
  • Men with partners who can have children must use a condom during the study and for at least 48 hours after stopping the study drug.
  • The person must be able to communicate well with the study team and be willing to follow the study rules, including attending all study visits.

Who cannot join the trial?

7 criteria

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis cannot participate. This is a specific lung disease that causes scarring of the lungs.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients with certain medical conditions that could interfere with the study results may not be eligible to participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.
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Investigated drugs

Treprostinil is a medication used in this clinical trial to help people with idiopathic pulmonary fibrosis. It is administered through inhalation, which means it is breathed in directly into the lungs. The goal of using treprostinil in this study is to see if it can improve lung function over a period of time, specifically by measuring changes in lung capacity from the start of the trial to one year later. This medication works by helping to open up the blood vessels in the lungs, which can improve breathing and reduce symptoms associated with the disease.

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 effectiveness and safety in treating idiopathic pulmonary fibrosis, a condition that causes lung scarring. The main therapeutic indication for treprostinil in this context is to improve lung function by increasing the forced vital capacity (FVC) over a period of 52 weeks. At the molecular level, treprostinil works by dilating blood vessels and reducing inflammation, which helps improve blood flow and oxygen delivery in the lungs. It is classified pharmacologically as a prostacyclin analog, which is a type of medication that mimics the effects of a naturally occurring substance in the body that helps to widen blood vessels.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The exact cause of the disease is unknown, which is why it is termed "idiopathic." Over time, the scarring makes it difficult for the lungs to transfer oxygen into the bloodstream. Patients may experience symptoms such as shortness of breath, a persistent dry cough, and fatigue. The disease typically progresses over several years, with symptoms gradually worsening.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514761-19-00Protocol codeRIN-PF-303Estimated enrolment815 patientsSponsorUnited Therapeutics Corp.

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