Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03950739
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2019-05-09
Brief Title:
Open-label Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Open-label Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder TreT in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREEZE
Brief Summary:
This is a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT
Detailed 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 satisfactionpreference 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 drugdevice becomes commercially available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None