Registry for Pulmonary Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial gathers real-world data on patients with pulmonary hypertension (high blood pressure in the lungs) associated with interstitial lung disease (lung scarring). It aims to understand patient outcomes with or without a specific inhaled medication called Tyvaso. Participants may fit into one of three groups: those not using the inhaled medication, those who recently started it, or those already on it for more than two months. Individuals with lung disease and confirmed high blood pressure in the lungs, who are not on certain other treatments, might be suitable candidates.
As a Phase 4 trial, this research provides insights into how the already FDA-approved and effective treatment benefits more patients, offering valuable information for those considering participation.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are taking inhaled treprostinil or Yutrepia, you may not be eligible for certain cohorts.
What prior data suggests that Tyvaso/Tyvaso DPI is safe for patients with pulmonary hypertension associated with interstitial lung disease?
Research has shown that Tyvaso and Tyvaso DPI, both inhaled treatments for pulmonary hypertension, have promising safety results. In earlier studies, patients using Tyvaso maintained stable oxygen levels in their blood, indicating a positive safety profile. Another study found that Tyvaso DPI was safe for long-term use in patients with a related condition. Additionally, the FDA has already approved Tyvaso for other uses, enhancing its safety reputation. Overall, these findings suggest that Tyvaso and Tyvaso DPI are generally well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about Tyvaso/Tyvaso DPI for treating pulmonary hypertension associated with interstitial lung disease because it offers a unique inhalation delivery method. Unlike other treatments that might be administered orally or via injection, Tyvaso/Tyvaso DPI delivers the active ingredient, treprostinil, directly to the lungs, potentially improving its effectiveness and reducing systemic side effects. This targeted approach not only enhances drug delivery but also allows for more rapid action, which is crucial for managing symptoms and improving the quality of life for patients with this condition.
What evidence suggests that Tyvaso/Tyvaso DPI is effective for pulmonary hypertension associated with interstitial lung disease?
Research has shown that Tyvaso (treprostinil) can help treat pulmonary hypertension linked to interstitial lung disease (PH-ILD). In one study, patients using Tyvaso walked farther without excessive fatigue after just four weeks, with even better results by 12 weeks. Another study found that adding Tyvaso to current treatments further increased walking distance, suggesting improved heart and lung function. Long-term studies have also shown that Tyvaso is safe and well-tolerated. This trial includes different cohorts: Cohort 2 will include patients newly initiated on Tyvaso/Tyvaso DPI, while Cohort 3 will include those who have been receiving Tyvaso/Tyvaso DPI for more than 60 days. This offers hope that Tyvaso might improve symptoms for those with PH-ILD.36789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Registry Enrollment
Participants are enrolled into one of three cohorts based on their treatment status with Tyvaso/Tyvaso DPI
Data Collection
Assessments are completed for data collection in 6- or 12-month intervals, including pulmonary function tests, HRCT, vital signs, and more
Follow-up
Participants are monitored for clinical outcomes and survival data
What Are the Treatments Tested in This Trial?
Interventions
- Prospective study assessments
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Cohort 3 will include approximately 350 patients who have been receiving Tyvaso/Tyvaso DPI for \> 60 days prior to Baseline.
Cohort 2 will include approximately 150 patients who are newly initiated on Tyvaso/Tyvaso DPI. For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at Baseline or ≤ 60 days prior to Baseline.
Cohort 1 will include approximately 500 patients who are not receiving inhaled treprostinil at time of study enrollment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
United Therapeutics
Lead Sponsor
Dr. Martine Rothblatt
United Therapeutics
Chief Executive Officer since 1996
PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA
Dr. Michael Benkowitz
United Therapeutics
Chief Medical Officer since 2023
MD from Harvard Medical School
Citations
Long-term safety and efficacy of treprostinil dry powder ...
Conclusion: The BREEZE OEP successfully demonstrated the safety of long-term treatment with treprostinil DPI in patients with PAH. Clinical ...
TYVASO® INCREASE Study Efficacy
Patients who took TYVASO saw improvement in 6MWD starting as early as week 4 and reached statistical significance by week 12.
TYVASO® (treprostinil) Clinical Findings and Results
In a clinical study, people who added TYVASO to their current PAH medicine walked farther, improving their 6MWD in as soon as 6 weeks.
214324Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov
Studies with Tyvaso establishing effectiveness predominately included patients with NYHA. Functional Class III symptoms and etiologies of ...
Long-term safety and efficacy of treprostinil dry powder ...
The long-term outcomes of the BREEZE OEP demonstrated that treprostinil DPI was a safe and tolerable treatment option for patients with PAH that may provide ...
TYVASO® INCREASE Study Safety
There was no evidence that TYVASO, an inhaled vasodilator therapy, worsened oxygenation, suggesting it does not contribute to the undesirable effects of V/Q ...
tyvaso dpi - accessdata.fda.gov
Treprostinil systemic exposure (AUC0-5hr and Cmax) of Tyvaso DPI post-inhalation was approximately proportional to the doses administered (16 to 64 mcg). ...
TYVASO® (treprostinil) Inhaled PAH Treatment
Taking a dose is as simple as: · IMPORTANT SAFETY · Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, ...
TYVASO DPI® (treprostinil) Inhalation Powder
Each dose is inhaled in less than 2 seconds. The BREEZE study was designed to assess the safety and tolerability of switching from TYVASO to TYVASO DPI3.
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