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Long‑Term Safety and Tolerability of Treprostinil Palmitil Inhalation Powder 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

The study focuses on Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD), a condition in which high blood pressure in the lungs occurs together with scarring of lung tissue, leading to shortness of breath and reduced ability to exercise. The treatment being examined is an inhaled medication called Treprostinil Palmitil Inhalation Powder, also referred to by the code name TPIP, which is taken as a dry‑powder capsule that is breathed in.

The aim of the study is to evaluate the safety and tolerability of long‑term use of this medication. Participants who have previously taken part in an earlier trial will continue to receive the inhaled powder and will be followed for up to two years. During this time they will attend regular clinic visits where simple checks such as blood tests, heart rhythm monitoring (ECG), measurement of oxygen use, and basic physical examinations are performed. The study also includes a group receiving placebo for comparison.

Throughout the study, participants will undergo a short walking test (6MWD) to see how far they can walk in six minutes, and lung function tests that measure the amount of air they can force out (FVC) and the speed of airflow (FEV1). Blood samples will be taken to check levels of a heart‑stress marker (NT-proBNP). These assessments help researchers understand how the medication affects breathing ability, heart strain, and overall health over the long term.

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 visit and baseline assessments

    You attend the first study visit after joining the trial and provide written consent to participate.

    The study team performs a physical examination, measures vital signs such as blood pressure and heart rate, and records any use of supplemental oxygen.

    A 12‑lead electrocardiogram (ecg) is taken to evaluate heart rhythm.

    Blood samples are collected for laboratory tests, including measurement of NT‑proBNP, a marker that reflects heart stress.

    Your ability to walk is tested with the six‑minute walk distance (6mwd), which records how far you can walk in six minutes.

    Lung function is measured with tests called forced vital capacity (fvc) and forced expiratory volume in one second (fev1).

    You complete symptom questionnaires, including the lung disease questionnaire (l‑pf) and a general health survey (eq‑5d‑5l).

  2. Step 2

    Receiving the study medication

    You are given treprostinil palmitil inhalation powder for the duration of the study.

    Each dose contains 1280 µg of the active ingredient and is delivered as an inhalation powder capsule.

    The medication is to be inhaled according to the instructions provided by the study staff; the exact frequency (for example, once daily) will be explained at the visit.

  3. Step 3

    Daily medication administration

    You use the inhalation device to take the prescribed dose of treprostinil palmitil at home as instructed.

    The medication is taken for up to 104 weeks (two years) unless the study is stopped early for safety reasons.

  4. Step 4

    Regular follow‑up visits

    You return to the study site at scheduled intervals (for example, every 12 weeks) for safety monitoring.

    Each visit includes repeat measurements of vital signs, oxygen use, and a physical exam.

    Laboratory tests and a 12‑lead ecg are performed to check for any adverse effects.

    The six‑minute walk distance test and lung function tests (fvc and fev1) are repeated to assess any changes in your condition.

    Blood is drawn again to measure NT‑proBNP levels.

    You complete the same symptom questionnaires (l‑pf and eq‑5d‑5l) to track changes in symptoms and quality of life.

  5. Step 5

    Monitoring for disease worsening

    Throughout the study you are asked to report any hospitalizations related to heart or lung problems, a noticeable decline in the six‑minute walk distance (15 % or more), new signs of right‑heart failure, or any need for lung transplantation.

    These events are recorded as part of the study’s safety and efficacy evaluation.

  6. Step 6

    Final study visit and study completion

    At the end of the study period (up to 104 weeks) you attend a final visit where all assessments performed at baseline and during follow‑up are repeated.

    The final data are used to evaluate the long‑term safety and tolerability of treprostinil palmitil inhalation powder in participants with pulmonary hypertension associated with interstitial lung disease.

Who can join the trial?

5 criteria

  • You have already finished the earlier research called the lead‑in PH‑ILD TPIP Study INS1009‑311.
  • You are able to read, understand, and sign a written agreement called informed consent, which shows you agree to follow the study’s rules.
  • You agree not to join any other interventional trials or use investigational drugs or devices while you are in this study.
  • You are a male or female who falls within the age limits set by the study (the study includes both adults and children as defined by the researchers).
  • If you are considered a vulnerable participant (for example, a minor or someone who may need extra protection), you still must meet all the other requirements and may need additional permission.

Who cannot join the trial?

8 criteria

  • If you have had side effects (called adverse events) that the doctor believes were caused by the study drug and could be risky, you cannot take part.
  • If you are currently taking or are expected to need any medicines approved for pulmonary arterial hypertension (PAH)—such as prostacyclin, prostacyclin‑like drugs, endothelin receptor antagonists, soluble guanylate cyclase stimulators, or any approved treprostinil therapy for PH‑ILD—you cannot join. (Using a class of drugs called phosphodiesterase 5 inhibitors is allowed.)
  • If you are pregnant, breastfeeding, or could become pregnant without using reliable birth control, you cannot join the study.
  • If you have any other medical or mental health condition, or abnormal lab test results, that the doctor thinks could be unsafe, make it hard for you to finish the study, or could affect the study results, you cannot take part.
  • If you have pulmonary hypertension that belongs to WHO Group 1, 2, 4, or 5, or a Group 3 type that is not related to interstitial lung disease (for example, combined pulmonary fibrosis and emphysema), you cannot join.
  • If you have signs of left‑side heart failure (left ventricular failure), a type called HFpEF (heart failure with preserved ejection fraction), or pulmonary hypertension caused by left‑heart problems (post‑capillary PH), you cannot participate.
  • If your blood platelet count is lower than 50,000 per microliter (platelet count <50 × 10³/µL) or you have unexplained problems with blood clotting in repeated tests, you cannot join.
  • If you are known to be allergic (hypersensitivity) to treprostinil, the study drug TPIP, or any ingredients in the formulation (such as mannitol or leucine), you cannot take part.
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Investigated drugs

Treprostinil Palmitil Inhalation Powder is a medicine that is breathed in as a fine powder. It delivers a drug directly to the lungs where it helps widen the blood vessels that carry blood through the lungs. By doing this, it can lower the pressure in these vessels and make it easier for the heart to pump blood, which can improve breathing and exercise ability for people who have pulmonary hypertension linked to interstitial lung disease. In this study the medicine is being given for a long time to see how safe it is and how well people can tolerate it.

What is already known about the treatment

  • Placebo (inhalation powder capsules)

    This product is an inhaled powder capsule that contains no active drug and is used only as a control in the study. It is not a marketed medication and has no therapeutic use outside of clinical trials. Because it has no active ingredient, it does not have a mechanism of action or a pharmacological class. It serves to help researchers compare the effects of the real drug with a neutral substance.

  • Treprostinil Palmitil Inhalation Powder

    This medication is taken as an inhaled powder, with each dose delivering 1280 µg of the drug. It is currently an investigational product being studied for safety and long‑term use in patients with pulmonary hypertension linked to interstitial lung disease. The drug works by slowly releasing treprostinil, which relaxes the blood vessels in the lungs and lowers pressure, acting as a vasodilator. It belongs to the prostacyclin analog class of medicines.

Investigated diseases

Pulmonary Hypertension associated with Interstitial Lung Disease - It is a condition where the blood pressure in the lung arteries becomes elevated while the lung tissue shows scarring or inflammation. As the lung disease progresses, the pressure in these vessels rises, putting strain on the right side of the heart. This leads to increasing shortness of breath, fatigue, and reduced ability to exercise. Lung function may continue to decline, and oxygen levels can fall. The disease typically worsens gradually, with periods of symptom flare‑ups.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521769-29-00Protocol codeINS1009-312Estimated enrolment275 patientsSponsorInsmed Inc.

sourced from the EU Clinical Trials Register and site verification

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