Inhaled Vardenafil for Pulmonary Arterial Hypertension
(VIPAH-PRN 2B Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Respira Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing an inhaled medication called RT234. It aims to help people with pulmonary arterial hypertension (PAH) breathe better and exercise more easily. The medication works by widening the blood vessels in the lungs, making it easier for the heart to pump blood. RT234 is being developed to improve exercise tolerance and symptoms in patients with PAH.

Research Team

Ed Parsley, DO

Principal Investigator

Respira Therapeutics

Eligibility Criteria

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

I've had a scan that shows I don't have CTEPH.

I am between 18 and 80 years old.

My pulmonary arterial hypertension is stable without major treatment changes.

See 6 more

Exclusion Criteria

I am using non-oral medication for pulmonary arterial hypertension.

I have severe liver disease or hypertension related to liver problems.

I have irregular heartbeats that are sudden or not well-controlled.

See 21 more

Treatment Details

Interventions

RT234 (Phosphodiesterase-5 (PDE-5) Inhibitor)

Trial OverviewThe trial is testing RT234 - vardenafil inhalation powder delivered via an Axially Oscillating Sphere dry powder inhaler to see if it improves exercise ability in PAH patients. Participants will undergo a Cardiopulmonary Exercise Test (CPET) to measure the drug's effects.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: RT234 2.0 mg Cohort 3Experimental Treatment1 Intervention

RT234 at a capsule dose strength of 2.0 mg.

Group II: RT234 1.0 mg Cohort 2Experimental Treatment1 Intervention

RT234 at a capsule dose strength of 1.0 mg.

Group III: RT234 0.5 mg Cohort 1Experimental Treatment1 Intervention

RT234 at a capsule dose strength of 0.5 mg.