Phase 3 Study of Once Daily Treprostinil Palmitil Inhalation Powder for Adults with Pulmonary Arterial Hypertension

What this Trial Is About

Researchers are evaluating the effect of a 24-week once daily treatment with Treprostinil Palmitil Inhalation Powder TPIP compared to placebo on exercise capacity in adults with pulmonary arterial hypertension PAH. This Phase 3 randomized, double-blind study focuses on adults aged 18 to 75 years diagnosed with PAH, aiming to assess changes in their ability to walk measured by the 6-minute walk distance test. Participants are randomly assigned to receive either TPIP starting at 80 micrograms once daily, with the dose increased to the maximum tolerated amount up to 1280 micrograms, or a matching placebo, both for 24 weeks. The treatment is given via oral inhalation using a capsule-based dry powder inhaler device. The study monitors participants over this period to evaluate the effects of the treatment on PAH symptoms and exercise capacity. During the study, participants will undergo assessments including 6-minute walk tests at baseline and week 24, measurements of heart and lung function, blood tests for markers like NT-proBNP, and questionnaires assessing symptoms and impact of PAH. Researchers also measure clinical worsening events, risk scores, and drug concentrations in plasma. The total participation duration is approximately 24 weeks, with continuous monitoring of safety and treatment effects throughout this period.

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)