Inhaled Vardenafil for Pulmonary Arterial Hypertension
(VIPAH-PRN 2B Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhaled medication, RT234 (inhaled vardenafil), to determine if it can safely help people with pulmonary arterial hypertension (PAH) exercise more effectively and reduce shortness of breath. PAH is a condition where high blood pressure in the lungs' arteries makes activities like walking difficult. People with PAH who are on stable treatment and can walk at least 150 meters might be suitable for this trial. The trial will compare different doses of RT234 to identify the most effective one. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that participants have stable PAH-specific medication regimens for at least 3 months before starting and throughout the study. If you are on certain medications like vasodilators or vitamin K antagonists, you must maintain a stable dose for at least 1 month before starting the trial. Some medications, like riociguat and nitrates, must be stopped before the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that RT234, an inhaled form of vardenafil, is generally safe for people. In earlier studies, participants tolerated doses from 0.2 mg to 2.4 mg well, using the medicine up to four times a day for nine days without major problems.
The treatment was also tested on healthy volunteers and proved safe when inhaled. This suggests that RT234 could be a good option for those considering it for pulmonary arterial hypertension (PAH). While these results are encouraging, individual experiences may vary.12345Why do researchers think this study treatment might be promising for pulmonary arterial hypertension?
Researchers are excited about RT234 for pulmonary arterial hypertension because it offers a unique approach with its inhaled delivery method. Unlike current treatments that are often oral or intravenous, the inhalation method allows the medication to work directly in the lungs where it's needed most, potentially enhancing effectiveness and reducing side effects. Additionally, RT234 uses vardenafil, a well-known phosphodiesterase-5 (PDE5) inhibitor, which helps relax blood vessels and improve blood flow. This targeted delivery system could mean quicker relief of symptoms and improved quality of life for patients.
What evidence suggests that RT234 might be an effective treatment for pulmonary arterial hypertension?
Research has shown that inhaled vardenafil, also known as RT234, may help treat pulmonary arterial hypertension (PAH). In studies, RT234 helped patients exercise longer and with less effort. It also increased oxygen use during exercise, which is crucial for people with PAH. Additionally, the treatment improved blood flow in the lungs. These findings suggest it could effectively manage PAH symptoms.14678
Who Is on the Research Team?
Ed Parsley, DO
Principal Investigator
Respira Therapeutics
Are You a Good Fit for This Trial?
Adults aged 18-80 with a confirmed diagnosis of WHO Group 1 Pulmonary Arterial Hypertension (PAH) who can walk at least 150 meters and are on stable PAH medication may qualify. Exclusions include vision loss from optic neuropathy, use of non-oral PAH meds, recent pulmonary rehab, sudden hearing loss, Down syndrome, severe blood or heart conditions, liver disease, uncontrolled asthma or hypertension, certain infections in HIV patients.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single inhaled dose of RT234 to assess its effects on exercise capacity and dyspnea
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in vital signs and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- RT234
Find a Clinic Near You
Who Is Running the Clinical Trial?
Respira Therapeutics, Inc.
Lead Sponsor