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Treprostinil for Pulmonary Arterial Hypertension (BREEZE Trial)
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.
- Pulmonary Arterial Hypertension
BREEZE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BREEZE Trial Design
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Who is running the clinical trial?
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- You have severe limitations in physical activity according to your doctor's assessment.You have been diagnosed with pulmonary hypertension that is not related to a specific group of causes outlined in the inclusion criteria.You have a history of untreated sleep apnea, certain lung diseases, or significant heart problems.You can't breathe in as directed for the study.You have a condition that makes it hard for you to walk, or you rely on a machine that can't be easily moved for a walking test.You started pulmonary rehabilitation within 12 weeks before the first visit.You have had a severe allergic reaction to treprostinil or any ingredients in the study drug.You have been diagnosed with pulmonary arterial hypertension (PAH) according to specific categories defined by the World Health Organization (WHO).You have been taking Tyvaso for at least 3 months and are currently using it regularly, as prescribed.You are able to walk at least 150 meters without stopping.Your lung function test showed that you were able to breathe out a good amount of air in 1 second, and the ratio of air you can forcibly breathe out to the total lung capacity was good, in the past 6 months.
- Group 1: Tyvaso to TreT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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