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

Investigator: Sandeep Sahay, MD

Study Coordinator: Jennifer Lee

Status: Enrolling

ClinicalTrials.gov Number: NCT03950739

Phone: 713.363.7537

Protocol Number: Pro00021615

Description

United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) will be evaluated after switching to a corresponding dose of TreT. Patients will undergo PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients will be offered the opportunity to participate in the Optional Extension Phase until the study terminates or the drug/device becomes commercially available.
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