United Therapeutics
The primary purpose of this study is to evaluate the safety and tolerability of treprostinil administered with a soft mist inhaler (SMI) over 16 weeks in approximately 40 participants with PH-COPD.
SMI-PH-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, safety and tolerability study with secondary endpoints evaluating the efficacy of the study drug on exercise capacity and NT-proBNP. Eligible participants will be randomly assigned 1:1 to treprostinil SMI or placebo at the Baseline Visit and receive study drug over a 16-week period. Participants will return to the clinic for follow-up visits at Weeks 4, 8, 12, 15, and 16. Study drug will be administered via a combination drug-device product that consists of the SMI with an associated cartridge…
Inclusion Criteria: 1. Give voluntary informed consent to participate in the study 2. Are ≥18 years of age, inclusive, at the time of signing informed consent 3. Willing to undergo right heart catheterization (RHC) during Screening. A RHC performed within 12 months prior to the Baseline Visit is acceptable for determining eligibility, even if done without oxygen or vasodilator challenge, and repeat RHC is not required. The following parameters must be documented for eligibility: 1. Pulmonary vascular resistance ≥4 Wood units 2. Pulmonary capillary wedge pressure or left ventricular end…
Inhaled treprostinil administered via a SMI four times daily in concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL
Placebo administered via a SMI