Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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.

Official Title

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)

Details

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 of treprostinil SMI for PH-COPD is granted, or the study is discontinued by the Sponsor. Participants may remain in the study for up to 7.5 years.

Keywords

Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, pulmonary hypertension, lung disease, respiratory tract disease, chronic obstructive pulmonary disease, COPD, Lung Diseases, Respiratory Tract Diseases, treprostinil SMI (treprostinil inhalation spray), treprostinil SMI

Eligibility

You can join if…

Open to people ages 18 years and up

  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) and nonlactating and agree to use 1 of the following:
    1. Abstain from penile-vaginal intercourse (when it is in line with their preferred and usual lifestyle) OR
    2. 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.

  5. 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.

You CAN'T join if...

  1. Pregnant or lactating
  2. 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.
  3. 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.

Locations

  • University of California San Francisco Medical Center
    San Francisco California 94143 United States
  • Stanford Health Care
    Palo Alto California 94305 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT07923526
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated