Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Purpose This study proposes to investigate the safety, tolerability, and feasibility of transitioning patients with PAH from intravenous or subcutaneous prostacyclin analogs to inhaled treprostinil using a defined protocol. Twenty-one patients from three PH specialty referral centers will be enrolled in this 12-week, prospective, open-label study. If subjects meet inclusion and exclusion criteria, they will be switched from intravenous or subcutaneous prostacyclin analogs to inhaled treprostinil according to a defined transition protocol. Background Parenteral prostacyclin analogs improve exercise capacity and survival in patients with pulmonary arterial hypertension (PAH), however practical issues can limit their tolerability in some patients. The prostacyclin analogue treprostinil has been shown to improve exercise capacity and signs/symptoms of PAH, while delivered via four 2-3 minute inhalation periods per day. In addition, there is extensive worldwide experience with the subcutaneous and intravenous forms of treprostinil, with documented safety, efficacy, and tolerability. Prior published studies have examined the feasibility of prostacyclin transitions, including transition from intravenous epoprostenol to non-parenteral PAH treatments, from subcutaneous to intravenous treprostinil, and from intravenous prostanoids to subcutaneous treprostinil. There is currently no published experience examining the safety, tolerability and feasibility of transitioning patients from parenteral prostanoids to inhaled treprostinil.