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Testing Treprostinil Palmitil Inhalation Powder for Improving Exercise Ability in Patients with Pulmonary Hypertension Related to 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 looking at Pulmonary Hypertension Associated with Interstitial Lung Disease, which is a condition where high blood pressure develops in the blood vessels of the lungs in people who also have scarring and damage to their lung tissue. The treatment being tested is treprostinil palmitil inhalation powder, which is also known by the code name INS1009. This medicine is breathed in as a powder using a special inhaler device. Some people in the study will receive the active medicine while others will receive placebo. The purpose of this study is to evaluate the effect of treprostinil palmitil compared with placebo on exercise capacity, which means how far a person can walk.

During the study, people will be randomly assigned to receive either treprostinil palmitil inhalation powder or placebo. The medicine is taken by breathing it in through the mouth using an inhaler device. The study will measure how far people can walk in six minutes, which is called a six-minute walk test. This test helps doctors understand how well the lungs and heart are working together. The study will also look at other things like blood test results that show how the heart is functioning, how long it takes before symptoms get worse, and how the disease affects daily life and symptoms.

The main part of the study lasts for 24 weeks, which is about six months. During this time, people will visit the study site for regular check-ups and tests. The study will measure changes in walking distance at different times during treatment. Blood samples will be taken to measure levels of certain substances in the blood and to check how the medicine is working in the body. The study will also track any major health problems that might happen and will ask people questions about their symptoms and how they feel in their daily activities.

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

    Initial assessment and baseline measurements

    At the beginning of the study, your baseline condition will be assessed. This includes measurements that will serve as reference points for comparison throughout the trial.

    Your exercise capacity will be measured using a 6-minute walk test. This test measures how far you can walk in 6 minutes. You will perform this test twice during the initial assessment, with at least 4 hours between the two tests.

    Blood samples will be collected to measure NT-proBNP, a substance in your blood that can indicate how well your heart is functioning.

    A questionnaire called Living With Pulmonary Fibrosis will be completed to assess your symptoms and how they affect your daily life.

  2. Step 2

    Random assignment to treatment group

    You will be randomly assigned to receive either the study medication treprostinil palmitil inhalation powder or a placebo. A placebo looks identical to the study medication but contains no active ingredient.

    Neither you nor your medical team will know which treatment you are receiving. This is called a double-blind study design.

    The study medication or placebo will be provided as an inhalation powder in capsules. The capsules may contain different dosage strengths: 80 micrograms, 160 micrograms, 320 micrograms, or 640 micrograms.

    You will inhale the powder using a special inhaler device.

  3. Step 3

    Treatment period from start to week 20

    You will take the assigned treatment by inhalation according to the prescribed schedule. The exact frequency of administration will be provided by your study team.

    During this period, regular assessments of your exercise capacity will be performed using the 6-minute walk test. These tests will be conducted at specific time points to measure changes from your baseline.

    Blood samples will be collected at regular intervals to measure NT-proBNP levels and to determine the concentration of the study medication in your blood.

    You will continue to complete the Living With Pulmonary Fibrosis questionnaire at scheduled visits to track changes in your symptoms.

    If you are taking other medications for your underlying lung condition or PDE5 inhibitors (medications that help relax blood vessels in the lungs), you should continue taking them at the same dose throughout the study.

  4. Step 4

    Assessment at week 22

    At week 22, your exercise capacity will be measured using the 6-minute walk test. This test will be performed at a specific time called trough exposure, which means at the time when the medication level in your body is at its lowest point before the next dose.

    This measurement will be compared to your baseline to determine any changes in your walking ability.

  5. Step 5

    Primary assessment at week 24

    At week 24, the main assessment of the study will take place. Your exercise capacity will be measured using the 6-minute walk test at a time called peak exposure, which means when the medication level in your body is at its highest.

    This measurement will be compared to your baseline to evaluate the effect of the treatment on your ability to walk.

    Blood samples will be collected to measure NT-proBNP levels. The change from your baseline will be assessed, and it will be determined whether your levels have improved.

    You will complete the Living With Pulmonary Fibrosis questionnaire again, and the change in your symptom scores from baseline will be evaluated.

    Throughout the entire 24-week period, any worsening of your condition or significant health events will be monitored and recorded.

  6. Step 6

    Study completion

    After completing the 24-week treatment period and all required assessments, your participation in the main part of the study will be finished.

    Final evaluations will be performed to ensure your safety and to collect all necessary data.

Who can join the trial?

8 criteria

  • You must be at least 18 years of age or older at the time of signing the consent form
  • You must have a diagnosis of pulmonary hypertension (high blood pressure in the lungs) that is associated with interstitial lung disease (scarring or damage to the lung tissue)
  • You must have confirmation of fibrotic interstitial lung disease (scarring in the lungs) shown on a CT scan (a special type of imaging test) done during screening or within the past 12 months
  • You must have pulmonary hypertension confirmed by a right heart catheterization (a procedure where a thin tube is inserted into the heart to measure pressures) done during screening or within 12 months before screening, with specific measurements showing: average pressure in the lung arteries greater than 20, pressure in the left side of the heart 15 or less, and resistance in the lung blood vessels at least 4 units
  • You must be able to walk between 100 and 500 meters (about 328 to 1640 feet) during a 6-minute walk test (a test where you walk as far as you can in 6 minutes). This test will be done twice during screening, at least 4 hours apart, and the distances walked should not differ by more than 15 percent
  • If you are taking long-term medications for your underlying disease (such as drugs to treat lung scarring or immune system medications) or PDE5 inhibitors (medications that help blood vessels relax), you must have been on this treatment for at least 90 days and on a stable dose for at least 30 days before screening
  • Male participants and female participants who are able to become pregnant must use contraceptives (birth control methods) as required by local regulations for people participating in clinical studies
  • You must be able to provide signed informed consent (written agreement to participate) and follow the requirements and restrictions listed in the consent form and study protocol

Who cannot join the trial?

3 criteria

  • The study information provided does not contain specific exclusion criteria, which are the reasons why a patient cannot participate in the clinical trial.
  • Without detailed exclusion criteria listed in the study documents, it is not possible to identify specific medical conditions, medications, or other factors that would prevent participation.
  • Typically, exclusion criteria may include things like certain other health conditions, use of specific medications, pregnancy status, or recent participation in other studies, but these specific details are not available in the provided information.
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Investigated drugs

Treprostinil Palmitil Inhalation Powder is an inhaled medication being tested in this clinical trial. It is designed to help people with pulmonary hypertension, which is high blood pressure in the blood vessels of the lungs, when it occurs together with interstitial lung disease, a condition that causes scarring of the lung tissue. This medication is breathed in as a powder and works to help open up the blood vessels in the lungs, which may improve the ability to exercise and perform daily activities. The study will compare this medication to a placebo to see if it is effective and safe for treating this condition.

What is already known about the treatment

Treprostinil Palmitil Inhalation Powder – This medication is an inhaled powder form of treprostinil that is being studied in phase 3 clinical trials for treating pulmonary hypertension associated with interstitial lung disease, a condition where high blood pressure in the lungs occurs alongside scarring of lung tissue. The medication works at the molecular level by mimicking prostacyclin, a natural substance in the body that helps widen blood vessels in the lungs and reduces blood clotting, thereby improving blood flow and reducing the strain on the heart. It belongs to the pharmacological class of prostacyclin analogs and is administered through inhalation directly into the lungs. The main goal of current research is to determine if this treatment can improve patients' ability to exercise and perform daily activities compared to placebo.

Investigated diseases

Pulmonary Hypertension Associated with Interstitial Lung Disease – This is a condition where high blood pressure develops in the arteries of the lungs in people who also have scarring and inflammation of lung tissue. The disease occurs when interstitial lung disease, which causes stiffening and damage to the lung tissue, leads to increased pressure in the blood vessels of the lungs. As the condition progresses, the heart must work harder to pump blood through the narrowed lung arteries. This combination of lung tissue damage and increased blood pressure in the lungs makes it difficult for oxygen to pass from the lungs into the bloodstream. People with this condition typically experience shortness of breath, reduced ability to exercise, and fatigue that worsens over time. The disease represents a serious complication that can develop in patients with various types of interstitial lung diseases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521558-40-00Protocol codeINS1009-311Estimated enrolment361 patientsSponsorInsmed Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).