This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Inhaled treprostinil (6 mcg/breath) administered four times daily
Incidence of Adverse Events Among Participants through 48 Weeks
The incidence of adverse events among participants throughout the 48-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.
Time frame: 48 weeks
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Forced Vital Capacity (FVC) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48
Time frame: Baseline and Week 48
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