Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

Phase 3 Completed 121 enrolled Liquidia Technologies, Inc. Nuventra, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH).

Timeline

Start: 2018-01-02
Primary completion: 2019-05-06
Completion: 2019-11-25

Outcome

Met primary endpoint

release “INSPIRE study indicated the study has met its primary endpoint of safety and tolerability of LIQ861 at the two-month timepoint.” liquidia.com ↗

release “Previously reported primary endpoints from the INSPIRE study support the safety and tolerability profile of LIQ861” liquidia.com ↗

Publications

Roscigno R, Vaughn T, Anderson S, Wargin W, Hunt T, Hill NS. Pharmacokinetics and tolerability of LIQ861, a novel dry-powder formulation of treprostinil. Pulm Circ. 2020 Nov 19;10(4):2045894020971509. doi: 10.1177/2045894020971509. eCollection 2020 Oct-Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Treprostinil	Other / unclassified	25 ug	Other
Subject	Treprostinil	Other / unclassified	50 ug	Other
Subject	Treprostinil	Other / unclassified	75 ug	Other
Subject	Treprostinil	Other / unclassified	100 ug	Other
Subject	Treprostinil	Other / unclassified	125 ug	Other
Subject	Treprostinil	Other / unclassified	150 ug	Other