Treprostinil Palmitil for Pulmonary Arterial Hypertension
Trial Summary
What is the purpose of this trial?
This trial is testing an inhalable medicine called TPIP to see if it can help people with high blood pressure in their lungs by making it easier for blood to flow through their lung arteries.
Do I have to stop taking my current medications?
The trial requires participants to stay on their current pulmonary hypertension medications, which can include up to two drugs from specific classes like endothelin receptor antagonists, phosphoesterase type 5 inhibitors, or guanylate cyclase stimulators. There should be no change in these medications or their dosages for at least 30 days before the screening.
What data supports the idea that the drug Treprostinil Palmitil for Pulmonary Arterial Hypertension is an effective treatment?
The available research does not provide any data on Treprostinil Palmitil for Pulmonary Arterial Hypertension. Instead, it focuses on treatments for erectile dysfunction, such as alprostadil and sildenafil. Therefore, there is no information here to support the effectiveness of Treprostinil Palmitil for Pulmonary Arterial Hypertension.12345
What safety data is available for Treprostinil Palmitil in treating pulmonary arterial hypertension?
Treprostinil Palmitil, in its various formulations such as TPIP and TPIS, has been evaluated for safety in several studies. A Phase 1 study assessed the safety, tolerability, and pharmacokinetics of TPIP in healthy volunteers, indicating it is well-tolerated with fewer respiratory-related side effects compared to inhaled Treprostinil. Preclinical studies in animals showed that TPIS maintained high lung concentrations with low systemic exposure, and no cough was observed at doses where Treprostinil caused cough. Additionally, there was no evidence of tachyphylaxis with repeated dosing in rats. Overall, these studies suggest that Treprostinil Palmitil formulations are safe and may offer advantages over existing Treprostinil treatments.678910
Is Treprostinil Palmitil a promising drug for Pulmonary Arterial Hypertension?
Yes, Treprostinil Palmitil is a promising drug for Pulmonary Arterial Hypertension. It is designed to be inhaled, which allows it to work directly in the lungs and provide long-lasting effects. This means it can be taken less often, possibly just once a day, which is more convenient for patients. Studies show it works well in reducing lung and heart problems related to the disease and is better tolerated than some other forms of the drug.678911
Research Team
Eligibility Criteria
Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who are on stable PH therapy can join this trial. They must not smoke, have a history of certain heart diseases or infections, and women should use effective contraception. Participants need to be able to perform physical tests like walking.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Placebo (Drug)
- Treprostinil Palmitil (Prostacyclin Analogue)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor