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Treprostinil for Pulmonary Arterial Hypertension (BREEZE Trial)

Phase 1
Waitlist Available
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks beginning on week 7 until study termination, an average of 1 year
Awards & highlights

BREEZE Trial Summary

This trial will test if it is safe to switch PAH patients from Tyvaso to TreT and if TreT is well tolerated.

Eligible Conditions
  • Pulmonary Arterial Hypertension

BREEZE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks beginning on week 7 until study termination, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks beginning on week 7 until study termination, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with treatment-emergent adverse events [Safety and Tolerability]
Secondary outcome measures
Analysis of treprostinil plasma concentration (pharmacokinetics [PK])
Change in 6-Minute Walk Distance (6MWD) from Baseline to Week 3
Number of subjects with treatment-emergent adverse events [Long-term Safety and Tolerability] during an Optional Extension Phase
+2 more

BREEZE Trial Design

1Treatment groups
Experimental Treatment
Group I: Tyvaso to TreTExperimental Treatment1 Intervention
Each subject will receive a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil Inhalation Powder
2018
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
107 Previous Clinical Trials
13,336 Total Patients Enrolled
58 Trials studying Pulmonary Arterial Hypertension
8,178 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Treprostinil Inhalation Powder Clinical Trial Eligibility Overview. Trial Name: NCT03950739 — Phase 1
Pulmonary Arterial Hypertension Research Study Groups: Tyvaso to TreT
Pulmonary Arterial Hypertension Clinical Trial 2023: Treprostinil Inhalation Powder Highlights & Side Effects. Trial Name: NCT03950739 — Phase 1
Treprostinil Inhalation Powder 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950739 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can Treprostinil Inhalation Powder assist with?

"Treprostinil Inhalation Powder is often prescribed for NYHA Functional Class III Pulmonary Arterial Hypertension, but can also be useful in treating WHO Functional Class II-III Pulmonary Arterial Hypertension and other related conditions."

Answered by AI

Is there any remaining space in this trial for prospective participants?

"According to clinicaltrials.gov, this medical study is no longer accepting applicants despite its initial posting on September 17th 2019 and latest update from November 2nd 2022. There are however 757 other trials that remain open for participant enrollment at present."

Answered by AI

How many individuals have been selected to partake in this research?

"Unfortunately, recruitment for this clinical trial has been halted. After being posted on September 17th 2019 and most recently updated on November 2nd 2022, the study is no longer inviting candidates to participate. However, there are a total of 749 medical trials looking for individuals with pulmonary arterial hypertension and 8 studies utilizing Treprostinil Inhalation Powder actively recruiting participants."

Answered by AI

Has the FDA approved Treprostinil Inhalation Powder for medical use?

"Due to limited clinical data backing its effectiveness and safety, our Power team has assigned Treprostinil Inhalation Powder a score of 1 in the risk assessment."

Answered by AI

Has this sort of experiment ever been conducted previously?

"Currently, 8 ongoing trials of Treprostinil Inhalation Powder can be found across 93 cities and 6 countries. Its initial trial in 2018 was ran by United Therapeutics and had 76 participants. It successfully completed the Phase 3 stage for drug approval, with 46 further studies concluded since then."

Answered by AI

Are there any other investigations conducted with regards to Treprostinil Inhalation Powder?

"Treprostinil Inhalation Powder was first observed in a study conducted at Indiana University Healh North Hospital back in 2018. To date, there have been 46 completed trials and 8 active research initiatives; with numerous of these being located in Louisville, Kentucky."

Answered by AI

How many healthcare institutions are engaged in this experiment?

"This trial is enrolling participants at a variety of medical centres, including University of Louisville Pulmonary Research in Louisville, Kentucky; Sentara Norfolk General Hospital in Norfolk, Virginia and USC's Department of Medicine situated in Los Angeles. 19 other sites are available to be considered as well."

Answered by AI
~9 spots leftby Apr 2025