Study on Long-Term Safety and Effectiveness of Treprostinil Palmitil for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying a condition known as Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The treatment being tested in this study is called Treprostinil Palmitil Inhalation Powder, also known by its code name INS1009. This medication is designed to be inhaled as a powder, which means it is breathed in through the mouth to reach the lungs directly.

The purpose of this study is to evaluate the safety and tolerability of long-term use of Treprostinil Palmitil Inhalation Powder in people with PAH. Participants in the study will use the inhalation powder over a period of time, and their health will be monitored to see how well they tolerate the treatment and to check for any side effects. Some participants may receive a placebo, which looks like the treatment but does not contain the active medication. The study will help researchers understand how safe and effective the treatment is for managing PAH over an extended period.

Throughout the study, participants will have regular check-ups to monitor their condition and the effects of the treatment. These check-ups will include assessments of their physical health and any changes in their symptoms. The study aims to provide valuable information on the long-term use of Treprostinil Palmitil Inhalation Powder, which could lead to improved treatment options for people living with Pulmonary Arterial Hypertension.

1 joining the study

Upon joining the study, eligibility is confirmed through baseline screening assessments if more than 30 days have passed since the end of a previous related study.

Participants must have completed a prior study related to pulmonary arterial hypertension (PAH) to be eligible.

2 medication administration

The medication used in this study is treprostinil palmitil inhalation powder.

The medication is administered through inhalation.

Dosage strengths include 80 micrograms, 160 micrograms, or 320 micrograms, depending on the specific requirements of the study.

3 treatment duration

The study is designed to assess the long-term use of the medication.

Participants will be monitored over a period that may extend up to 24 months.

4 monitoring and assessments

Regular assessments will be conducted to monitor the safety and tolerability of the medication.

Primary assessments include tracking the frequency and severity of any adverse effects experienced during the study.

5 secondary assessments

Secondary assessments involve measuring changes in walking distance, blood markers, and functional capacity over time.

The study also tracks any clinical worsening events, such as hospitalizations or changes in medication.

Who Can Join the Study?

Participants must have completed the end of treatment visit in Study INS1009 201, Study INS1009 202, or any other initial study related to Pulmonary Arterial Hypertension (PAH). If the follow-up study was not available at the time, they can join within one year of finishing the initial study.
If more than 30 days have passed since the end of the initial study visit, participants must complete new baseline screening assessments to confirm they are eligible to participate.
Participants must be able to give signed informed consent, which means they agree to follow the rules and restrictions outlined in the consent form and the study protocol.
Participants who had any hypersensitivity (allergic reaction) or adverse drug reaction (bad side effects) or were withdrawn early from a previous PAH TPIP study, and if the study doctor believes that continuing treatment might be risky for them, may not be eligible.
Both male and female participants are eligible to join the study.
The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who Cannot Join the Study?

Patients who have not participated in previous studies related to the treatment being tested.
Patients with medical conditions other than Pulmonary Arterial Hypertension. This is a condition where the blood pressure in the arteries of the lungs is higher than normal.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who are currently participating in another clinical trial.
Patients with certain medical conditions that might interfere with the study or pose a risk to the patient.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Krankenhaus Neuwittelsbach	Munich	Germany
Odklejzvmzdgzo Lqnp Gmlq	Linz	Austria
Hqwmodji Uygctovqbxxno Mcipxet Dj Vjtxpfetsz	Santander	Spain
Aesaij Urzefdaggy Hsztwkgh	Aarhus	Denmark
Ujselxxxgr Dfmki Sgffm Dt Rvtg Lq Shoeyboq	Rome	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	12.12.2022
Belgium	Not recruiting	12.12.2022
Denmark	Not recruiting	12.12.2022
Germany	Not recruiting	12.12.2022
Italy	Not recruiting	12.12.2022
Spain	Not recruiting	12.12.2022

Trial locations

Investigated drugs:

Treprostinil Palmitil

Treprostinil Palmitil Inhalation Powder (TPIP) is a medication used in this clinical trial to help manage Pulmonary Arterial Hypertension (PAH). It is designed to be inhaled, allowing the medication to directly reach the lungs. The goal of using TPIP is to improve the symptoms of PAH by widening the blood vessels in the lungs, which can help reduce the pressure in these vessels and improve the ability to exercise. This study aims to assess how safe and tolerable TPIP is when used over a long period.

Investigated diseases:

Pulmonary arterial hypertension

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension (PAH) is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure is due to the narrowing or blockage of these small arteries, which makes it difficult for blood to flow through them. As a result, the heart has to work harder to pump blood through the lungs, which can lead to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the increased workload can cause the heart to enlarge and weaken. The progression of PAH can vary, with some individuals experiencing a gradual worsening of symptoms. It is considered a rare disease and can significantly impact daily activities and quality of life.

Trial ID:

2023-505539-11-00

Protocol code:

INS1009-203

NCT ID:

NCT05649748

Trial Phase:

Therapeutic use (Phase IV)

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Study on Long-Term Safety and Effectiveness of Treprostinil Palmitil for Patients with Pulmonary Arterial Hypertension

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?