Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of the long-term use of treprostinil palmitil inhalation powder (TPIP) in participants with Pulmonary Arterial Hypertension (PAH) from studies INS1009-201, INS1009-202, and other lead-in studies of treprostinil palmitil inhalation powderTPIP in participants with PAH.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/13/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Charles Burger, M.D.

Open for enrollment

Contact information:

Kevin Kurtz M.S.

Kurtz.Kevin@mayo.edu

More information

Publications

Publications are currently not available