United Therapeutics
The purpose of this study is to evaluate the long-term impact of treprostinil SMI on safety and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study.
SMI-PH-202 is an open-label extension (OLE) study evaluating the long-term impact of treprostinil SMI on safety, tolerability, and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study. Eligible participants will be enrolled and initiate open-label treprostinil SMI in a single arm; there is inherently no control or comparator arm. Participants will return for in-clinic visits at Weeks 4 and 12 and every 12 weeks thereafter. Treatment with treprostinil SMI will continue until the participant either prematurely discontinues treatment, marketing approval…
Inclusion Criteria: 1. Voluntarily give informed consent to participate in the study 2. Willing and able to comply with scheduled study visits, study treatment, laboratory tests, and all other study-related procedures 3. Enrolled in a previous study evaluating treprostinil SMI for PH-COPD, remained on study drug, and completed the study OR Enrolled in a previous study evaluating treprostinil SMI for PH-COPD when the study was discontinued by the Sponsor for reasons other than safety 4. Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at study entry…
Inhaled treprostinil administered via a SMI four times daily in concentrations of 1.34, 2.68, 4.02, 5.36, and 6.70 mg/mL