A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
This clinical trial is looking at a medicine called treprostinil palmitil inhalation powder. It is designed for adults living with pulmonary hypertension associated with interstitial lung disease (PH-ILD). In this condition, scarring in the lungs causes high blood pressure in the blood vessels that supply the lungs, leading to severe breathlessness and fatigue. This is an open-label extension study, which means participants and doctors know which treatment is being given. Researchers want to understand the long-term safety of the inhaled powder over up to two years (104 weeks). They will also measure how well the treatment helps people walk further, supports lung function, and lowers the chance of sudden flare-ups or hospital stays. Taking part involves regular clinic visits for breathing checks, heart traces, walking tests, and quality-of-life surveys.
At a glance
What is this study about?
Interstitial lung disease involves scarring and stiffness of the lung tissue. When this scarring puts extra strain on the blood vessels in the lungs, blood pressure inside them rises. This combination is known as pulmonary hypertension associated with interstitial lung disease, or PH-ILD. It can make everyday activities like walking or climbing stairs very difficult, leaving people breathless and exhausted.
Treprostinil palmitil is an experimental medicine breathed directly into the lungs using a dry powder inhaler. The goal of the medicine is to help relax and widen the narrowed blood vessels in the lungs. Widening these vessels can reduce pressure, lower the workload on the heart, and make it easier for oxygen to get into the bloodstream.
Because this is an extension study, it allows researchers to check what happens when people use the medicine over a longer period—up to two years. Doctors will closely track safety, see if participants can walk further during a six-minute walking test, and find out whether the treatment helps improve daily energy levels and well-being.
Key takeaways
- The study tests an inhaled powder for people with pulmonary hypertension linked to lung scarring.
- It is a long-term safety study running for up to two years (104 weeks).
- All participants receive the active study medicine without placebos.
- Clinic visits include walking tests, lung capacity checks, and quality-of-life surveys.
- Taking part is voluntary, and you can withdraw at any point.
Who may be eligible?
This study is open to adults aged 18 and older who have pulmonary hypertension linked to interstitial lung disease. Generally, to enter an extension study like this, you must have already taken part in an earlier qualifying study testing this treatment.
You will need to be able to use a dry powder inhaler correctly and be willing to attend regular hospital check-ups over the course of two years. These check-ups include simple walking and breathing tests.
You might not be able to join if your health is too unstable, if you are unable to carry out the breathing tests, or if your doctor feels an experimental inhaled medicine is not safe for your personal circumstances.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
- I have taken part in a previous qualifying clinical trial for this medicine.
- I am able to use a handheld dry powder inhaler.
- I am willing to attend regular clinic appointments over a two-year period.
What does participation involve?
Taking part lasts for up to 104 weeks (about two years). You will be prescribed the study medicine as a dry powder in capsules, which you breathe in using a personal inhaler device.
You will visit the study clinic regularly for routine health checks. During these visits, the team will check your blood pressure, listen to your chest, run routine blood tests, and record your heart rhythm with an electrocardiogram (ECG). You will also do lung function tests (blowing into a tube) and a six-minute walking test to see how far you can comfortably walk. In addition, you will fill in short questionnaires about your cough, breathing, and daily energy levels.
Potential risks and benefits
Locations (12)
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- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedDenmark
- —UnverifiedGermany
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- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedRomania
Common questions
What does 'open-label' mean?
It means both you and the research doctors know exactly which medicine and dose you are receiving, with no dummy treatments (placebos) used during this extension period.
How is the medicine taken?
The medicine comes in small capsules containing dry powder. You place a capsule inside a special inhaler device and breathe the powder into your lungs.
Will I have to pay for the study treatment?
No. The study medicine, tests, and trial-related care are provided free of charge.
What is the six-minute walk test?
It is a gentle test that measures how far you can walk at your own comfortable pace in six minutes on a flat hallway, with rests whenever you need them.
Can I leave the study early if I want to?
Yes. You are free to withdraw from the study at any time, for any reason, and your regular medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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