CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled / 42 target
Drug / intervention
Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)combination
Likely dose
0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04266197
NCT04266197Phase 2CompletedMonitor (0.6/mo)Completion was 19mo ago
CompareCT.gov

A Phase 2b, Open-label, Single Dose Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)

Respira Therapeutics, Inc.·interventional·Posted Feb 12, 2020·Updated Jun 17, 2026

In Brief

A Phase 2 clinical trial evaluating Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) for Pulmonary Arterial Hypertension. Completed, enrolled 42 participants across 26 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The objectives of this study are to evaluate the safety of RT234 and the effects of RT234 on exercise capacity as assessed by Cardiopulmonary Exercise Testing (CPET) and six minute walk testing (6MWT) as well as exertional symptoms in patients with pulmonary arterial hypertension (PAH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 12, 2020
Enrollment StartSep 25, 2020
Primary CompletionNov 20, 2024
Study CompletionJan 7, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.4 years ago

Arms & Interventions

RT234 0.5 mg Cohort 1experimental

RT234 at a capsule dose strength of 0.5 mg.

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)
RT234 1.0 mg Cohort 2experimental

RT234 at a capsule dose strength of 1.0 mg.

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)
RT234 2.0 mg Cohort 3experimental

RT234 at a capsule dose strength of 2.0 mg.

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)

Interventions

Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)combination

RT234 capsules of a dry powder formulation containing vardenafil administered via oral inhalation with a non-invasive AOS DPI.