Active not recruitingPHASE2, PHASE3INTERVENTIONAL

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

This study is an extension to see how safe and well-tolerated a new inhaled medicine, Treprostinil Palmitil (TPIP), is when used over a longer period. It's designed for people who have Pulmonary Arterial Hypertension (PAH) and have already taken part in previous studies of TPIP. The main goal is to check for any long-term side effects or problems. This type of research helps doctors understand if new treatments can be used safely for a long time. Participants will continue to receive either TPIP or a dummy treatment (placebo), and their health will be monitored closely.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Insmed Incorporated

Enrolment target

Start

07 Mar 2023

Estimated completion

31 Dec 2026

Pulmonary Arterial Hypertension

What is this study about?

This research is an extension study for a medicine called Treprostinil Palmitil, which is given as an inhaled powder. It's for people who have a serious lung condition called Pulmonary Arterial Hypertension (PAH). PAH makes the blood vessels in the lungs narrow, making it hard for the heart to pump blood, which can lead to breathlessness and tiredness. The main aim of this particular study is to keep a close eye on the safety of TPIP when people use it over a longer time. We want to understand if there are any long-term effects, good or bad, and how well people tolerate the treatment when it's used for an extended period. This is really important before a new medicine can be widely used.

This study isn't looking for new participants to start the treatment for the first time. Instead, it's open to people who have already completed other studies involving TPIP for PAH. By continuing to follow these participants, researchers can gather more information about the medicine's long-term safety and how well it helps manage PAH symptoms over time. This helps build a full picture of the treatment's benefits and any potential risks.

Knowing how safe a medicine is over a long time is crucial. It helps doctors make informed decisions about prescribing treatments and helps patients understand what to expect. This study is a vital step in the process of thoroughly testing new medicines to make sure they are as safe and effective as possible for people living with PAH.

Key takeaways

This study prolongs previous research on an inhaled medicine for PAH.
It focuses on the long-term safety and tolerability of Treprostinil Palmitil (TPIP).
Only people who completed earlier TPIP studies for PAH can join.
Participants will continue to receive either TPIP or a placebo.
Your health will be closely monitored throughout the study period.

Who may be eligible?

This study is for people who have already taken part in previous studies of an inhaled medicine called Treprostinil Palmitil (TPIP) for their Pulmonary Arterial Hypertension (PAH).

To join, you must have completed your last visit in one of the specific earlier TPIP studies. If a long time has passed since your last visit in those studies (more than 30 days), you might need some new health checks to ensure you're still suitable for this extension study.

You cannot join if you've started certain other strong PAH medicines (like injected forms of prostacyclin) since your last study. If you've developed new serious heart problems, blood clots in your lungs, active liver disease, new cancers (except for fully treated skin or cervical cancer), or severe recent COVID-19, you also won't be able to take part. You also can't be taking part in any other drug or device trial.

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.

Did you complete an earlier study testing Treprostinil Palmitil (TPIP) for PAH?
Have you started other strong injected pulmonary hypertension medicines recently?
Have you developed any new serious heart problems?
Have you had a new diagnosis of cancer (excluding treated skin or cervical cancer)?
Are you currently involved in another medical research study?
Do you currently have severe COVID-19 or were recently hospitalised for it?

Answer every question to see your result.

What does participation involve?

This study is an extension, so you would have already taken part in an earlier study of TPIP. The exact details of visits and tests will depend on how long it has been since your last study visit, but generally, you will continue to receive either the study medicine (TPIP) or a dummy treatment (placebo) that you may have been on previously. You will have regular appointments where doctors will check your general health, measure your breathing, perform heart checks, and take blood samples. They will also ask about any side effects you might be experiencing. The overall length of time you take part is not specified but will be for a longer period to assess the medicine's safety over time.

Potential risks and benefits

Participating in this study might offer a potential benefit of continuing to receive a treatment that could help manage your PAH, and you'll receive careful medical monitoring. However, as with any medicine, there's a risk of side effects, which would be explained fully by the study team. Some participants might receive a placebo, meaning they won't be getting the active drug. You are free to leave the study at any time for any reason without it affecting your medical care.

Locations (45)

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

USA005
Verified postcode
Jacksonville, United States
USA011
Verified postcode
Tampa, United States
USA006
Verified postcode
Chicago, United States
USA001
Verified postcode
Chicago, United States
USA102
Verified postcode
New York, United States
USA016
Verified postcode
Dallas, United States
ARG009
Verified postcode
Quilmes, Argentina
ARG006
Verified postcode
Rosario, Argentina
ARG007
Verified postcode
San Miguel de Tucumán, Argentina
ARG004
Verified postcode
Córdoba, Argentina
ARG001
Verified postcode
Córdoba, Argentina
AUT002
Verified postcode
Linz, Austria

Common questions

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a rare but serious condition where the blood vessels in your lungs become narrow. This makes it harder for your heart to pump blood, leading to symptoms like shortness of breath and tiredness.

What is Treprostinil Palmitil (TPIP)?

TPIP is an inhaled medicine, meaning you breathe it in. It's being studied as a possible treatment for PAH to help open up the blood vessels in the lungs.

Why is this study only for people who were in earlier TPIP studies?

This is an 'extension' study. Its main purpose is to see how safe TPIP is over a longer period in people who have already been exposed to it, rather than starting treatment for the first time.

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

Often in these types of studies, participants don't know whether they are receiving the active medicine or a placebo to ensure fair results. The study team will explain how this works.

What if my health changes during the study?

Your health will be monitored regularly by the study team, and you should always report any new or worsening symptoms. They will provide guidance and care based on your condition.