Open-Label Multicenter Study Evaluating Safety and Tolerability of Dry Powder Inhaled Treprostinil LIQ861 in Adults with Pulmonary Hypertension Associated with Interstitial Lung Disease

What this Trial Is About

Researchers are studying the safety and tolerability of LIQ861, a dry powder inhaled form of treprostinil, in people with Pulmonary Hypertension PH classified as WHO Group 1 and Group 3. The study includes two groups Cohort A with about 60 people who have PH associated with interstitial lung disease PH-ILD, and Cohort B with about 20 people who have PH-ILD and are already on inhaled treprostinil but not meeting treatment goals and can switch to LIQ861. Participants in Cohort A will receive LIQ861 and be monitored for safety and tolerability. Cohort B participants will transition from their current inhaled treprostinil treatment to LIQ861 and be observed for 16 weeks. This open-label, multicenter study involves using LIQ861 inhalation powder with an inhaler to deliver the medication. During the study, participants will have assessments including lung imaging, right heart catheterization, and 6-minute walk tests to evaluate their condition. Researchers will record any drug or device-related side effects or serious adverse events throughout the study. The total participation may last until the study end date, with primary safety outcomes observed up to 16 weeks for Cohort B and throughout the study for Cohort A.

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