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A study to evaluate the safety and effectiveness of inhaled treprostinil in patients with pulmonary hypertension associated with interstitial lung disease

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What is this trial about?

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

This study is being conducted to evaluate the safety and effectiveness of a new inhaled medication called L606, which contains treprostinil liposome, for people living with Pulmonary Hypertension associated with Interstitial Lung Disease. This condition is a type of high blood pressure in the lungs that occurs in individuals who also have scarring or inflammation of the lung tissue. The treatment is delivered through inhalation, which means the medication is breathed in through the lungs.

Participants in the study will be assigned to receive either L606 or a placebo. This research involves a randomized and double-blind process, meaning that neither the participants nor the researchers know which specific treatment is being administered until the study is finished. The study will monitor how the medication affects the ability to walk and other health factors over a period of time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of treatment

    The treatment involves using an inhaled powder or inhaled solution containing treprostinil liposome.

    The dose for the treprostinil liposome is 950 micrograms administered via inhalation.

  2. Step 2

    Placebo administration

    Some participants will receive a placebo, which is an inhalation suspension that does not contain the active medicine.

  3. Step 3

    Monitoring and evaluation

    The progress is measured by the six-minute walk test, which tracks the distance walked in six minutes to evaluate how the medicine affects physical ability.

    Changes in the six-minute walk distance are monitored at week 16 and week 24.

  4. Step 4

    Clinical observation

    The study tracks specific clinical worsening events, which include death, hospitalization for heart or lung issues related to the underlying disease, the need for a lung transplant, or a significant decrease in walking distance.

Who can join the trial?

8 criteria

  • You must be between 18 and 80 years old.
  • You must have a confirmed diagnosis of interstitial lung disease (ILD), which is a condition where scarring or inflammation makes it difficult for the lungs to work properly, as seen on a special detailed chest scan called a High Resolution Computed Tomography (HRCT).
  • You must show signs of pulmonary hypertension, which is high blood pressure in the arteries of the lungs, confirmed through a procedure called Right Heart Catheterization (RHC) where a thin tube is used to measure pressure in the heart.
  • Your pulmonary vascular resistance (PVR), which measures how much force is needed to push blood through the lung vessels, must be 320 dynes.sec/cm5 or higher.
  • Your mean Pulmonary Artery Pressure (mPAP), which is the average amount of pressure in the main artery of the lungs, must be 25 mmHg or higher.
  • Your pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP), which are measurements used to check the pressure inside the left side of the heart, must be 15 mmHg or lower.
  • Your FEV1/FVC ratio, which is a calculation used to check how much air you can breathe out quickly compared to the total amount of air you can hold, must be greater than 0.70.
  • You must be able to walk at least 150 meters during a six-minute walk test, which is a test used to measure how much exercise you can handle.

Who cannot join the trial?

7 criteria

  • You cannot participate if your pulmonary hypertension (high blood pressure in the lung arteries) is categorized into other specific groups (Groups 1, 2, 4, or 5) according to the official medical classification.
  • You cannot participate if an echocardiogram (an ultrasound used to look at the heart) shows significant problems with the left side of your heart.
  • You cannot participate if you have a history of atrial fibrillation (an irregular or uneven heartbeat) that is constant or cannot be controlled with medicine.
  • You cannot participate if you have severe obstructive sleep apnea (a condition where your breathing repeatedly stops and starts while you are sleeping).
  • You cannot participate if you have recently had a sudden worsening of your lung condition or an active lung infection that requires antibiotics (medicine used to kill bacteria).
  • You cannot participate if you have recently started pulmonary rehabilitation (a specialized program of exercise and education designed to help people with lung disease).
  • You cannot participate if you have severe coronary heart disease (serious damage to the blood vessels that supply the heart), unstable angina (chest pain that is unpredictable or worsening), or have had a myocardial infarction (a heart attack) within the last 180 days.
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Investigated drugs

Treprostinil is an inhaled medication used to treat pulmonary hypertension, a condition where the blood pressure in the lungs is too high. In this study, it is delivered as an inhalation powder or solution to help improve how well a person can walk and to manage the symptoms of high blood pressure in the lungs associated with lung disease.

What is already known about the treatment

  • Treprostinil Liposome

    This medication is an inhaled powder or solution used to treat high blood pressure in the lungs, specifically for patients with lung disease. It belongs to a class of drugs known as prostacyclin analogues that work by mimicking a natural substance in the body to relax and widen the blood vessels. On a molecular level, it stimulates specific receptors on the surface of blood vessel cells to improve blood flow and reduce pressure. While treprostinil is well-established in medical literature for lung conditions, this specific liposome version is being studied for its effectiveness in a new delivery format.

  • L606 Placebo Inhalation Suspension

    This is an inactive substance delivered through inhalation that looks and feels like the active medication but contains no medicinal ingredients. It is used in clinical trials as a comparison tool to help researchers determine if the actual drug is truly effective. Because it has no active chemical components, it does not work on any biological processes or molecular targets in the body. This allows scientists to distinguish between the real effects of the treatment and any changes that might happen by chance.

Investigated diseases

Pulmonary hypertension associated with interstitial lung disease - This condition occurs when there is high blood pressure in the arteries of the lungs caused by underlying lung tissue damage. The interstitial lung disease causes scarring or inflammation within the lung tissue, making it difficult for the lungs to expand and transfer oxygen. As the lung tissue becomes stiffer, the blood vessels in the lungs are compressed or damaged. This resistance forces the heart to work harder to pump blood through the lungs. Over time, the increased pressure in the lung arteries can lead to further changes in the blood vessels. The condition typically progresses as the lung damage and vascular resistance increase.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517943-29-00Protocol codeL606-301Estimated enrolment343 patientsSponsorLiquidia Technologies Inc.

sourced from the EU Clinical Trials Register and site verification

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