An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
• An Institutional Review Board (IRB) approved informed consent is signed and dated by the subject prior to any study related activities.
• Male or Females between 18 years to 75 years of age at Screening. Subjects between 76 and 80 years of age at Screening can be considered for eligibility but will require approval of the Sponsor's MM or designee.
• If the subject is a female of childbearing potential, then the subject must have a negative pregnancy test result at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the subject is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control are not necessary. It is the Investigator's responsibility for determining whether the subject has adequate birth control for study participation.
• Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed within 12 months prior to baseline visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) \>70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) within 6 months of the baseline visit with the following documented parameters depending on their lung disease category a) or b).
• a. Subjects may have any form of ILD or combined pulmonary fibrosis and emphysema (CPFE).
• i) Pulmonary vascular resistance (PVR) \> 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of \< 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of \> 30 mmHg
• OR b. A exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) \> 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of \< 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of \> 21 mmHg
• Must be able to walk a distance of \>125 meters on two six-minute walk tests (6MWTs) during the screening and baseline assessments. The variability of the distances between the two qualifying 6MWTs must be within 15% of one another, calculated from the furthest walk.
• Subjects on a chronic medication for underlying lung disease (i.e. pifenidone, nintedanib, etc) must be on a stable dose and regimen for \> 30 days prior to Baseline and planned to continue for the duration of the study at the same dose.
• Demonstrates the ability to use the RS00 Model 8 inhaler.