Not recruitingRare disease

Study on Treprostinil Palmitil Inhalation Powder for Patients with Pulmonary Hypertension and 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 clinical trial is focused on studying the effects of a treatment for Pulmonary Hypertension associated with Interstitial Lung Disease. The treatment being tested is called Treprostinil Palmitil Inhalation Powder, also known by its code name INS1009. This medication is administered as an inhalation powder, which means it is breathed in through a device designed for this purpose. The study also involves a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to evaluate the safety and tolerability of long-term use of Treprostinil Palmitil Inhalation Powder in participants with Pulmonary Hypertension associated with Interstitial Lung Disease. Participants who have completed previous related studies are eligible to join this extension study. The study will monitor participants over a period of time to observe any side effects and to assess how well the treatment is tolerated. Participants will be asked to use the inhalation powder regularly and attend follow-up visits to track their progress.

Throughout the study, various health measurements will be taken to assess the effectiveness of the treatment. These include tests to measure lung function and exercise capacity, as well as blood tests to check for specific markers related to the disease. The study aims to provide valuable information on the long-term use of Treprostinil Palmitil Inhalation Powder, which could help improve treatment options for people with Pulmonary Hypertension associated with Interstitial Lung Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study related to pulmonary hypertension with interstitial lung disease. Eligibility is confirmed through baseline screening assessments if more than 30 days have passed since the last study visit.
Step 2
Medication administration
The medication used is treprostinil palmitil inhalation powder. It is administered through inhalation. Dosage strengths include 80 micrograms, 160 micrograms, or 320 micrograms, depending on the specific requirements of the study.
Step 3
Monitoring and assessments
Regular assessments are conducted to monitor safety and effectiveness. These include measuring the distance walked in six minutes (6MWD), lung function tests such as FVC and FEV1, and blood tests for NT-proBNP concentration.
Assessments occur at specific intervals: Month 6, Month 12, Month 18, and Month 24. Additional evaluations include questionnaires to assess quality of life and any changes in health status.
Step 4
Tracking clinical events
The study tracks the frequency and severity of any adverse events. Clinical worsening events, such as hospitalization or the need for additional therapy, are also monitored.
Step 5
Study duration
The study is expected to continue until April 15, 2026. Participation involves regular follow-ups and adherence to the study protocol throughout this period.

Who can join the trial?

5 criteria

Participants must have completed the end of treatment visit in Study INS1009-211 or any other related study for **Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)**. This means they have finished a previous study related to their lung condition.
If the new study was not available when they finished the previous study, they can still join within one year of completing the previous study.
If more than 30 days have passed since the end of their previous study, participants need to complete some initial checks to confirm they can join the new study. These checks are called **baseline screening assessments**.
Participants must be able to understand and sign a document called **informed consent**. This document explains what they need to do and any rules they need to follow during the study.
Both male and female participants are eligible to join the study.

Who cannot join the trial?

5 criteria

Patients who have not participated in Study INS1009-211 or other related studies involving TPIP for Pulmonary Hypertension Associated with Interstitial Lung Disease. This condition involves high blood pressure in the lungs due to lung disease.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Responsive
Essen, Germany
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

Trial locations

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Investigated drugs

Treprostinil Palmitil Inhalation Powder (TPIP) is a medication being studied for its long-term safety and effectiveness in treating pulmonary hypertension associated with interstitial lung disease. It is administered as an inhalation powder, which means it is breathed in through the mouth using a special device. This medication is designed to help improve blood flow in the lungs, which can reduce the symptoms of pulmonary hypertension and improve the patient's ability to exercise and perform daily activities.

Treprostinil Palmitil

What is already known about the treatment

Treprostinil Palmitil – This medication is administered as an inhalation powder and is currently being studied in clinical trials for its long-term safety and effectiveness. It is primarily used for treating pulmonary hypertension associated with interstitial lung disease. Treprostinil Palmitil works by dilating blood vessels in the lungs, which helps to lower blood pressure and improve blood flow. It belongs to the pharmacological class of prostacyclin analogs, which are known for their ability to mimic the effects of natural prostacyclin, a substance in the body that helps to relax blood vessels and inhibit blood clot formation.

Investigated diseases

Pulmonary Hypertension Associated with Interstitial Lung Disease – This condition involves high blood pressure in the blood vessels of the lungs, occurring alongside interstitial lung disease, which affects the tissue and space around the air sacs of the lungs. The disease progresses as the blood vessels in the lungs become narrowed, blocked, or destroyed, leading to increased pressure and strain on the heart. Over time, this can cause the heart to weaken and struggle to pump blood effectively. Symptoms may include shortness of breath, fatigue, dizziness, and swelling in the legs and ankles. As the condition advances, these symptoms can become more pronounced, affecting daily activities and quality of life.