BREEZE Optional Extension Phase: Long-term safety and efficacy of treprostinil dry powder inhaler (Tyvaso DPI) in pulmonary arterial hypertension - 22/10/25

Doi : 10.1016/j.rmed.2025.108318

Sandeep Sahay ^a, Harold Palevsky ^b, Karim El-Kersh ^c, Ricardo Restrepo-Jaramillo ^d, Abubakr A. Bajwa ^e, Sapna Desai ^f, Joanna M. Joly ^g, Leslie A. Spikes ^h, Michael S. Eggert ⁱ, Shilpa Johri ^j, Shelley M. Shapiro ^k, Micah R. Fisher ^l, Trushil G. Shah ^m, Gautam V. Ramani ⁿ, Jinesh P. Mehta ^o, Claire M. Thrasher ^p, Chunqin Deng ^p, Peter Smith ^p, Meredith Broderick ^p, Charles D. Burger ^q,^⁎
^a Division of Pulmonary, Critical Care and Sleep Medicine, Houston Methodist Hospital, 6445 Main St, Houston, TX, 77030, USA
^b Perelman School of Medicine of the University of Pennsylvania, Penn Presbyterian Medical Center, 3737 Market St, Philadelphia, PA, 19104, USA
^c Department of Medicine, Division of Pulmonary Critical Care and Sleep Medicine, University of Arizona College of Medicine, 1111 East McDowell Rd, Phoenix, AZ, 85006, USA
^d University of South Florida, 2 Tampa General Cir, Tampa, FL, 33606, USA
^e Mayo Clinic College of Medicine & Science, Department of Pulmonary, Allergy & Sleep Medicine Mayo Clinic, 4500 San Pablo Rd S, Jacksonville, FL, 32224, USA
^f John Ochsner Heart and Vascular Institute, Ochsner Medical Center, 1514 Jefferson Hwy, New Orleans, LA, 70121, USA
^g Division of Cardiovascular Disease, UAB Department of Medicine, 500 22nd St S, Birmingham, AL, 35233, USA
^h Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA
ⁱ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Sentara Cardiovascular Research Institute, 600 Gresham Dr, Norfolk, VA, 23507, USA
^j Pulmonary and Critical Care Medicine, Pulmonary Associates of Richmond Inc, 6600 W Broad St, Richmond, VA, 23230, USA
^k Division of Cardiology, VA Greater Los Angeles Healthcare System, Division of Pulmonary Critical Care, David Geffen UCLA School of Medicine, 200 Medical Plaza, Los Angeles, CA, 90095, USA
^l Emory University Division of Pulmonary Allergy, Critical Care and Sleep Medicine, 1365 Clifton Rd NE, Atlanta, GA, 30322, USA
^m Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine University of Texas Southwestern Medical Center, 5939 Harry Hines Blvd, Dallas, TX, 75390, USA
ⁿ Division of Cardiology, University of Maryland, 419 West Redwood St, Baltimore, MD, 21201, USA
^o Pulmonary and Critical Care Medicine, The Cleveland Clinic, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA
^p United Therapeutics Corporation, 55 T.W. Alexander Dr, Durham, NC, 27709, USA
^q Department of Pulmonary and Critical Care Medicine, Mayo Clinic, 4500 San Pablo Rd S, Jacksonville, FL, 32224, USA

^⁎Corresponding author.

Abstract

Introduction

Pulmonary arterial hypertension (PAH) is a rare and progressive disease associated with significant morbidity and mortality. Prostacyclins, including treprostinil, are a mainstay of PAH treatment, particularly in patients with intermediate to high risk of death. Following the approval of treprostinil inhalation solution for PAH, treprostinil dry powder inhaler (DPI) was developed as a small, portable, low-maintenance device to improve patient experience.

Objective

The primary objective of the BREEZE study was to assess the safety and tolerability of treprostinil DPI in PAH.

Methods

BREEZE was a 3-week, single-arm, open-label study in which patients with PAH transitioned from a stable dose of treprostinil inhalation solution to a comparable dose of treprostinil DPI.

Results

Following the 3-week treatment phase, 49 of 51 patients opted to enroll in the Optional Extension Phase (OEP). Throughout the OEP, 6MWD continued to increase with a median change from baseline of 16 m at week 107 and over a third of patients experiencing an improvement of at least 30 m. Patient satisfaction with the DPI device was overwhelmingly positive while drug-related adverse events were infrequent and characteristic of prostacyclin therapy.

Conclusion

The BREEZE OEP successfully demonstrated the safety of long-term treatment with treprostinil DPI in patients with PAH.

Clinical trial registration

NCT03950739.

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Graphical abstract

Image 1

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Highlights

•	49/51 BREEZE patients enrolled in the optional extension phase.
•	Median follow-up was 107 weeks; median treprostinil DPI dose at week 107 was 80 mcg.
•	Over a third of patients improved their 6-min walk distance by at least 30 m.
•	Patient satisfaction with the DPI was overwhelmingly positive.
•	Long-term use of treprostinil DPI in PAH was safe and may provide clinical stability.

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Keywords : Treprostinil, Dry powder inhaler, Pulmonary arterial hypertension, Prostacyclin dosing, Exercise capacity

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Acknowledgements/funding

Objectives & endpoints

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Article 108318- novembre 2025 Retour au numéro

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BREEZE Optional Extension Phase: Long-term safety and efficacy of treprostinil dry powder inhaler (Tyvaso DPI) in pulmonary arterial hypertension - 22/10/25

Abstract

Introduction

Objective

Methods

Results

Conclusion

Clinical trial registration

Graphical abstract

Highlights

Plan

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