29 Participants Needed

Inhaled Treprostinil for Pulmonary Hypertension

YR
CI
Overseen ByColleen Irlbeck
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing an inhaled medication called treprostinil on patients with a lung condition that makes it hard for them to exercise. The medication helps by improving blood flow in the lungs. Researchers want to see if it makes exercise easier and improves quality of life after a period of use. Treprostinil has been shown to improve exercise capacity and is more convenient due to its longer-lasting effects.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is inhaled Treprostinil safe for humans?

There is no relevant safety information about inhaled Treprostinil in the provided research articles.12345

What makes the drug Tyvaso DPI unique for treating pulmonary hypertension?

Tyvaso DPI is unique because it is a portable, breath-powered inhaler that delivers treprostinil as a dry powder, making it easier to use compared to nebulizers. It targets the peripheral lungs effectively with minimal drug loss and is preferred by patients for its convenience and non-invasive nature.678910

What data supports the effectiveness of the drug Treprostinil for pulmonary hypertension?

Inhaled Treprostinil, such as Tyvaso DPI, is effective for treating pulmonary hypertension by improving walk distance in patients with symptoms. It is a patient-preferred option due to its ease of use and portability, and it has shown similar effectiveness and patient satisfaction compared to other forms of Treprostinil.678910

Who Is on the Research Team?

YN

Yogesh N Reddy, M.B.B.S

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults over 18 with suspected PAH-ILD undergoing right heart catheterization, and healthy volunteers without lung disease or pulmonary hypertension. It's not for anyone under 18.

Inclusion Criteria

Undergoing cardiac catheterization for clinical indications at Mayo Clinic Rochester over a 12-month period.
I am suspected to have high blood pressure in the lungs due to lung disease and will undergo a heart procedure.
I am healthy with no lung, heart, muscle diseases or high blood pressure in the lungs.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inhaled treprostinil and undergo RHC while exercising

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Treprostinil
Trial Overview The study is testing the drug treprostinil inhaled by patients with PAH-ILD to see how it affects their ability to exercise and quality of life after three months. Some may undergo optional muscle biopsies or RHC while exercising.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PAH-ILD PatientsExperimental Treatment3 Interventions
Group II: Healthy VolunteersExperimental Treatment2 Interventions

Treprostinil is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Remodulin for:
🇪🇺
Approved in European Union as Remodulin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

United Therapeutics

Industry Sponsor

Trials
112
Recruited
14,500+

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

Published Research Related to This Trial

Treprostinil (Remodulin) is a new treatment option for pulmonary hypertension, highlighting its potential as an effective therapy for this condition.
The study outlines a comprehensive multidisciplinary management plan that includes a flow chart to address high-risk issues associated with the use of treprostinil, emphasizing the importance of safety in its administration.
Patient safety challenges in treprostinil therapy.Roncesvalles, A., Lee, FW., Camamo, J., et al.[2017]
Tyvaso DPI is a portable, breath-powered inhaler that delivers treprostinil for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, offering a passive administration method that enhances patient compliance.
In clinical studies, Tyvaso DPI demonstrated similar drug exposure and safety profiles to nebulized treprostinil, with a low incidence of adverse events and high patient satisfaction, making it a suitable option for patients seeking a convenient and effective treatment.
Tyvaso DPI: Drug-device characteristics and patient clinical considerations.McEvoy, C., Argula, R., Sahay, S., et al.[2023]
Treprostinil is an effective treatment for pulmonary arterial hypertension (PAH) and is available in three formulations: intravenous/subcutaneous (Remodulin®), inhaled (Tyvaso®), and oral (Orenitram®).
Pharmacokinetic studies in both healthy volunteers and PAH patients provide important insights that can help clinicians make informed decisions about the most suitable route of administration for individual patients.
A Comprehensive Review of Treprostinil Pharmacokinetics via Four Routes of Administration.Kumar, P., Thudium, E., Laliberte, K., et al.[2018]

Citations

Patient safety challenges in treprostinil therapy. [2017]
Tyvaso DPI: Drug-device characteristics and patient clinical considerations. [2023]
A Comprehensive Review of Treprostinil Pharmacokinetics via Four Routes of Administration. [2018]
Inhaled treprostinil for the treatment of pulmonary arterial hypertension. [2017]
Comparative bioavailability of inhaled treprostinil administered as LIQ861 and Tyvaso® in healthy subjects. [2021]
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