Inhaled Vardenafil for Pulmonary Arterial Hypertension

(VIPAH-PRN 2B Trial)

Recruiting at 28 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Respira Therapeutics, Inc.

Must be taking: Endothelin antagonists, PDE5 inhibitors

Must not be taking: Riociguat, Nitrates

Disqualifiers: Hypotension, Asthma, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

42 Participants Needed

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.

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.

What data supports the effectiveness of the drug RT234 for pulmonary arterial hypertension?

Research shows that RT234, which delivers vardenafil to the lungs, can reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension. Additionally, vardenafil has been effective in improving exercise capacity in similar conditions, suggesting potential benefits for this drug in treating pulmonary arterial hypertension. ^{1 2 3 4 5}

Is inhaled vardenafil (RT234) safe for humans?

Inhaled vardenafil (RT234) was generally safe and well tolerated in a study with healthy adults, with the most common side effect being mild-to-moderate headaches. There was no evidence of lung irritation or inflammation, and no significant drug accumulation was observed with repeated doses. ^{1 2 4 5 6}

How is the drug RT234 different from other treatments for pulmonary arterial hypertension?

RT234 is unique because it delivers vardenafil directly to the lungs through inhalation, which allows for rapid absorption and is designed to improve exercise tolerance and symptoms on an 'as needed' basis, unlike other treatments that are taken orally and focus on long-term symptom management. ^{1 2 3 4 5}

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.

My pulmonary arterial hypertension is stable without major treatment changes.

I have been on a stable dose of my current medications for at least 1 month.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single inhaled dose of RT234 to assess its effects on exercise capacity and dyspnea

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in vital signs and adverse events

30 days

Treatment Details

Interventions

• RT234

Trial Overview The 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

Group I: RT234 2.0 mg Cohort 3 Experimental Treatment 1 Intervention

RT234 at a capsule dose strength of 2.0 mg.

Group II: RT234 1.0 mg Cohort 2 Experimental Treatment 1 Intervention

RT234 at a capsule dose strength of 1.0 mg.

Group III: RT234 0.5 mg Cohort 1 Experimental Treatment 1 Intervention

RT234 at a capsule dose strength of 0.5 mg.

Who Is Running the Clinical Trial?

Respira Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

90+

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of RT234 vardenafil inhalation powder on exercise parameters in pulmonary arterial hypertension: phase II, dose-escalation study design. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Vardenafil treatment for patients with pulmonary arterial hypertension: a multicentre, open-label study. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Vardenafil and weaning from inhaled nitric oxide: effect on pulmonary hypertension in ARDS. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improvement of exercise capacity in monocrotaline-induced pulmonary hypertension by the phosphodiesterase-5 inhibitor Vardenafil. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of RT234 (Vardenafil Inhalation Powder): A First-in-Human, Ascending Single- and Multiple-Dose Study in Healthy Subjects. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Long-term vardenafil therapy improves hemodynamics in patients with pulmonary hypertension. [2015]