Long-term study of inhaled treprostinil for lung blood pressure in COPD
Tests inhaled treprostinil long term in adults with COPD-related lung high blood pressure.
Plain-language title generated from the registry record
Registry title: An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Key facts
- Where
- Boston, Chapel Hill, Charleston, Chicago, Dallas, Detroit, Falls Church, Lexington, Palo Alto, Philadelphia, Phoenix, Pittsburgh, San Francisco, and Tucson, United StatesSee the 15 sites
- Phase
- Phase 2/3
Where in United States
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- University of Chicago Medical CenterChicago, United StatesNo longer taking part
- Baylor University Medical CenterDallas, United StatesNo longer taking part
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- Inova Fairfax HospitalFalls Church, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- Stanford Health CarePalo Alto, United StatesNo longer taking part
- Temple University HospitalPhiladelphia, United StatesNo longer taking part
- Banner-University Medical Center PhoenixPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- University of California San Francisco Medical CenterSan Francisco, United StatesNo longer taking part
- University of Arizona - Banner HealthTucson, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- United Therapeutics
- Trial code
- NCT07923526
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
An Open-label Extension Study of Treprostinil Administered Via a Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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.
Inclusion: Voluntarily give informed consent to participate in the study; Willing and able to comply with scheduled study visits, study treatment, laboratory tests, and all other study-related procedures; 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; Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at study entry) and nonlactating and agree to use 1 of the following:; Abstain from penile-vaginal intercourse (when it is in line with their preferred and usual lifestyle) OR; Use medically acceptable, highly effective contraception for the duration of the study and at least 30 days after discontinuing study drug; Medically acceptable, highly effective forms of contraception include approved hormonal contraceptives (oral, injectable, transdermal, intravaginal, and implantable), hormonal or non-hormonal intrauterine devices or systems, or monogamous intercourse with a partner who has undergone vasectomy. Barrier methods alone or with spermicide may be considered with Sponsor approval, if they have a proven track record of excellent compliance. Note: Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, bilateral tubal occlusion, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months and >50 years of age or in the documented clinical opinion of a Women's Health Specialist) are not considered to be WOCBP for study purposes; Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion: Use of any other investigational drug/device or participation in any investigational study in which the participant received a medical intervention (ie, procedure, device, medication/supplement). Participation in non-interventional, observational, or registry studies is permitted; Developed a concurrent illness or condition when using treprostinil SMI for PH-COPD in a previous study, which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study; Pregnant or lactating.