A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)

Summary

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

Timeline

Start

2018-05-08

Primary completion

2022-10-13

Completion

2022-10-13

Publications

• Nathan SD, Argula R, Trivieri MG, Aziz S, Gay E, Medarov B, Parambil J, Raina A, Risbano MG, Thenappan T, Soto JS, Bell H, Lacasse V, Sista P, Di Marino M, Smart A, Hawkes B, Nelson E, Bull T, Tapson V, Waxman A. Inhaled treprostinil in pulmonary hypertension associated with COPD: PERFECT study results. Eur Respir J. 2024 Jun 6;63(6):2400172. doi: 10.1183/13993003.00172-2024. Print 2024 Jun.

Drugs

Indications