Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

This study is for people who have high blood pressure in their lungs, which is connected to a condition where their lungs become scarred (Interstitial Lung Disease). The main purpose of the study is to see how safe a new inhaled powder medicine, called Treprostinil Palmitil, is when taken for a long time. Researchers will also check if it causes any unwanted side effects and if it helps people breathe better or walk further. Participants will use an inhaler with different doses of the medicine. Scientists will closely monitor their health, lung function, and how well they can walk over several months to understand the long-term effects of this treatment.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Insmed Inc.

Enrolment target

Start

26 Apr 2024

Pulmonary Hypertension Associated with Interstitial Lung Disease

What is this study about?

This research study is looking into a new inhaled medicine for a serious condition called pulmonary hypertension (PH) that happens alongside interstitial lung disease (ILD). PH means the blood pressure in the arteries leading to your lungs is too high, making your heart work much harder. ILD is a group of diseases that cause scarring in the lungs, making it hard to breathe. When you have both, it can be very challenging.

The study wants to find out if a medicine called Treprostinil Palmitil Inhalation Powder can be safely used for a long time by people with this specific combination of lung conditions. Researchers are especially interested in seeing if the medicine causes any side effects and how severe they might be. They also want to understand if it helps people feel better, breathe more easily, or improve how far they can walk.

To do this, participants will use an inhaler with different strengths of the medicine. The study will carefully measure things like how well your lungs are working, how far you can walk in six minutes, and your general quality of life over many months. This will help doctors understand if this new treatment is a good option for people living with pulmonary hypertension linked to interstitial lung disease.

Key takeaways

This study evaluates a long-term inhaled treatment for lung conditions.
It focuses on safety and how well people tolerate the medicine.
It also checks if the medicine improves breathing and walking.
Participants are usually those who were in a previous study of this medicine.
The study lasts for up to two years with regular check-ups.

Who may be eligible?

To be part of this study, you generally need to be an adult, 18 years old or older. The study is open to both men and women.

Since this is an "extension study," it usually means that you've already taken part in a previous study testing this medicine. So, this study is designed for people who have already started treatment with Treprostinil Palmitil Inhalation Powder in an earlier part of the research.

The research team will have a more detailed list of criteria to make sure the study is right for you and to keep you safe. They will check your medical history and current health carefully to see if you can take part.

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.

Are you 18 years old or older?
Do you have pulmonary hypertension linked to interstitial lung disease?
Have you previously taken part in a study testing Treprostinil Palmitil Inhalation Powder?
Are you able to attend regular clinic visits and perform required tests?
Are you comfortable using an inhaler for medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be using an inhaled medicine called Treprostinil Palmitil. This medicine comes in capsules for an inhaler, and there are different strengths (doses) that you might receive. You'll continue to take this medicine for an extended period, potentially up to two years.

Throughout the study, you'll have regular visits to the clinic. At these visits, doctors will perform various assessments. This includes checks for any side effects you might experience, tests to see how well your lungs are working (like breathing into a machine), and a 6-minute walking test to see how far you can walk. You might also have blood tests and fill out questionnaires about your quality of life. The research team will explain the schedule of these visits and tests, which will occur at specific times like every six months. The total duration of your involvement could be up to 24 months (two years).

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new treatment that might help manage your condition, potentially improving your breathing, walking ability, and overall quality of life. However, like all medicines, Treprostinil Palmitil may cause side effects, which the study will monitor closely. These are called 'adverse events,' and the researchers will track their frequency and severity. You will be told about all known risks before you decide to join. Remember, taking part in a study is completely voluntary, and you have the right to withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy
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Unverified
Germany
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Unverified
Belgium

Common questions

What is Pulmonary Hypertension Associated with Interstitial Lung Disease?

It's a condition where you have high blood pressure in the arteries that go to your lungs, and this is linked to scarring or thickening of the lung tissue.

What is an 'inhalation powder'?

It's a medicine in a dry powder form that you breathe in using a special device called an inhaler, so the medicine goes directly into your lungs.

What does 'safety and tolerability' mean in a study?

It means the researchers are looking at how safe the medicine is by checking for side effects (safety) and how well people can cope with those side effects (tolerability).

What's a 6-minute walking test?

It's a simple test where you walk as far as you can in six minutes, and it helps doctors measure your exercise ability and overall fitness.

Will I know if I'm getting the actual medicine or a dummy medicine?

Because this is an 'open-label extension study,' it means that both you and the study team will know you are receiving the active Treprostinil Palmitil Inhalation Powder and not a placebo.