Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and
Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary
Hypertension

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Pulmonary conditions
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All genders
person-wave 18-75
world
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Overview
Principal Investigator: Ioana Preston, MD

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.

Study details
Inclusion Criteria
  • 1. Must be able to walk a distance of >125 meters on two six-minute walk tests (6MWTs) during the screening and baseline assessments.
  • 2. 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.
  • 3. Demonstrates the ability to use the RS00 Model 8 inhaler.
Exclusion Criteria
  • 1. Pulmonary hypertension (PH) in the Updated WHO Classification Groups 1, 2, 4, or 5.
  • 2. Intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  • 3. Received any FDA approved PAH or PH-ILD prostacyclin therapy including: epoprostenol, treprostinil, iloprost, beraprost, or IP receptor agonist (selexipag), except for acute vasoreactivity testing within 60 days of Screening
Study Requirements

Participation in this study will last 52 weeks or more until the study drug is approved by the FDA for the treatment of PH-ILD or until the study is discontinued by the Sponsor. These visits will occur at Screening, Baseline, Week 8, Week 16, Week 24, Week 52 and every 24 weeks thereafter until the study drug is approved by the FDA or until the study is discontinued by the Sponsor. Blood collection will occur at screening, baseline, Weeks 8, 16, 24 and 52 with blood collection of around 1 tablespoon each time for a total of 6 tablespoons. There will be two CT scans for research purposes at baseline and week 24.