A Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Treprostinil Palmitil
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.
Sites / Locations
- USA006Recruiting
- USA016Recruiting
- ARG006Recruiting
- ARG007Recruiting
- GER005Recruiting
- ITA002Recruiting
- JPN002Recruiting
- JPN003Recruiting
- MYS002Recruiting
- PHL002Recruiting
- GBR001Recruiting
Arms of the Study
Arm 1
Experimental
Treprostinil Palmitil Inhalation Powder (TPIP)
Participants who are not transitioning immediately from other TPIP studies: INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies, will be administered TPIP, once daily (QD), at a starting dose of 80 micrograms (μg), up-titrated to the highest tolerated dose between 80 μg and 640 μg during 3-week titration period. The overall treatment period will be 24 months. Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received: TPIP- will be administered placebo QD (80 μg up to achieved TPIP dose from previous study) along with the achieved TPIP dose from previous study in a blinded manner during 3-week titration period. Placebo- will be administered TPIP QD (80 μg up to achieved placebo dose from previous study) along with the achieved placebo dose from previous study in a blinded manner during 3-week titration period. The overall treatment period will be 24 months.