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

Launched by INSMED INCORPORATED · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and tolerability of a medication called Treprostinil Palmitil Inhalation Powder (TPIP) for people with a condition known as Pulmonary Arterial Hypertension (PAH). PAH affects the blood vessels in the lungs, making it harder for blood to flow and causing symptoms like shortness of breath. The trial is open to men and women aged 65 to 74 who have previously completed other studies with TPIP. To join, participants must meet specific health criteria, such as not having started certain other treatments or having significant heart or lung issues since their last study.

If you or a loved one are eligible and decide to participate, you will be closely monitored while using TPIP over an extended period. This helps researchers understand how well the medication works and its effects on your health. It's important to know that there are some health requirements to ensure safety, including not having current serious health conditions like active heart disease or recent COVID-19. Overall, this study aims to provide more information about TPIP, which could help improve treatment options for PAH in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
• • Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study.
• Exclusion Criteria:
• • Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
• • Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
• • New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
• • New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
• • Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
• • Interval organ transplantation.
• • New active liver disease or hepatic dysfunction.
• • Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
• • Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study.
• • Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days.
• • Participants who currently inhale marijuana (recreational or medical).
• • Note: Other inclusion/exclusion criteria may apply.