Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso

Summary

This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.

Timeline

Start

2019-09-17

Primary completion

2023-08-22

Completion

2023-08-22

Outcome

Met primary endpoint

release “Top line data showing the BREEZE study met its primary objective were released in January 2021” unither.com ↗

Publications

• Sahay S, Palevsky H, El-Kersh K, Restrepo-Jaramillo R, Bajwa AA, Desai S, Joly JM, Spikes LA, Eggert MS, Johri S, Shapiro SM, Fisher MR, Shah TG, Ramani GV, Mehta JP, Thrasher CM, Deng C, Smith P, Broderick M, Burger CD. BREEZE Optional Extension Phase: Long-term safety and efficacy of treprostinil dry powder inhaler (Tyvaso DPI) in pulmonary arterial hypertension. Respir Med. 2025 Nov;248:108318. doi: 10.1016/j.rmed.2025.108318. Epub 2025 Aug 27.
• Spikes LA, Bajwa AA, Burger CD, Desai SV, Eggert MS, El-Kersh KA, Fisher MR, Johri S, Joly JM, Mehta J, Palevsky HI, Ramani GV, Restrepo-Jaramillo R, Sahay S, Shah TG, Deng C, Miceli M, Smith P, Shapiro SM. BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI in patients with pulmonary arterial hypertension. Pulm Circ. 2022 Apr 7;12(2):e12063. doi: 10.1002/pul2.12063. eCollection 2022 Apr.

Drugs

Indications