Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

A vizsgálat adatai

Ki végzi

United Therapeutics

Azonosító

NCT07923591

A regiszteradat frissítve

2026. november 6.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Tolerability of Treprostinil Administered Via a Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

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.

Bevonási feltételek: Give voluntary informed consent to participate in the study; Are ≥18 years of age, inclusive, at the time of signing informed consent; 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:; Pulmonary vascular resistance ≥4 Wood units; Pulmonary capillary wedge pressure or left ventricular end diastolic pressure ≤15 mmHg; Diagnosis of PH-COPD (WHO Group 3) with the following documented parameters at Screening:; FEV1 ≥35%; FEV1/FVC <70%; Resting SpO2 ≥90%, with or without supplemental oxygen by any mode of delivery and supplemental O2 ≤8 L/min at rest at Screening; If on chronic COPD medication, must be on a stable and optimized dose for ≥45 days prior to the Baseline Visit; Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at Screening and Baseline) 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 agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug; In the opinion of the Investigator, able to communicate effectively with study site staff, and considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Kizáró feltételek: Known intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy; Received any PAH-approved therapy within 60 days prior to Baseline. As needed (PRN) use of a PDE5-I (eg, sildenafil, tadalafil, vardenafil) for erectile dysfunction is permitted. Daily use of a PDE5-I, even if for an indication other than PH, is not allowed; Confirmed diagnosis of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease, or interstitial lung disease. Redacted computed tomography scan results conducted within 6 months prior to Baseline must be provided to the Sponsor's Medical Monitor with the Pre Baseline Form to confirm eligibility; Previous diagnosis of homozygous alpha-1 antitrypsin deficiency; Myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline; Recent exacerbation of COPD and/or active pulmonary or upper respiratory infection that required hospitalization, symptomatic treatment, or treatment with antibiotics and/or corticosteroids:; If hospitalized, within 180 days prior to Baseline; If not hospitalized, within 90 days prior to Baseline; Initiation of pulmonary rehabilitation within 12 weeks prior to Baseline or, in the opinion of the Investigator, pulmonary rehabilitation is likely to be needed during the Treatment Period; 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) within 30 days prior to Baseline. Participation in non-interventional, observational, or registry studies is permitted; Any form of congenital heart disease (repaired or unrepaired) other than a patent foramen ovale; In the opinion of the Investigator, the participant has any condition that would interfere with the interpretation of study assessments, study participation or cooperation, or has any disease or condition (ie, peripheral vascular disease, musculoskeletal disorder, morbid obesity) that would likely be the primary limit to ambulation (as opposed to PH); Evidence of clinically significant left-sided heart disease (including, but not limited to, left ventricular ejection fraction <40% and/or left ventricular hypertrophy) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor's Medical Monitor is required; 6MWD <150 meters during Screening; DLCO ≤25% during Screening; Pregnant or lactating; Confirmed diagnosis of PAH or PH for any reason other than associated with COPD; Unable or unwilling to use Sponsor-provided devices (eg, SMI).

ClinicalTrials.gov NCT07923591