An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

Korábbi kezelés

• 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.

Egyéb

• Pregnant or lactating

• 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.