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)

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).

Start Date25 Sep 2020

Sponsor / Collaborator

Respira Therapeutics, Inc.

NCT05343637 / CompletedPhase 2

A Phase 2a, Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension

This multicenter, open label, Phase 2a study is designed to evaluate the effect of inhaled RT234 delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with Pulmonary Arterial Hypertension (PAH) undergoing Right heart catheterization (RHC).
This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2a (VIPAH-PRN 2a) study

Start Date30 Jul 2019

Sponsor / Collaborator

Respira Therapeutics, Inc.

NCT05567367 / CompletedPhase 1

A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects

The objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of RT234 in healthy volunteers.
This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 1 (VIPAH-PRN 1) study

Start Date31 Jul 2018

Sponsor / Collaborator

Respira Therapeutics, Inc.

100 Clinical Results associated with Respira Therapeutics, Inc.

0 Patents (Medical) associated with Respira Therapeutics, Inc.

Literatures (Medical) associated with Respira Therapeutics, Inc.

01 Aug 2021·Journal of Aerosol Medicine and Pulmonary Drug DeliveryQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: Eldon, Michael A. ; Parsley, Edwin L. ; Weers, Jeffry G. ; Okikawa, Jerry ; Tarara, Thomas E. ; Maurer, Mari

Background: RT234 (vardenafil inhalation powder) is being developed for pulmonary administration "as needed", to acutely improve exercise tolerance and symptoms in patients with pulmonary arterial hypertension (PAH). Methods: This single-center, open-label, randomized study in 32 healthy adult subjects evaluated single and multiple inhalation doses of RT234, for safety, tolerability, and pharmacokinetics (PKs). Results: RT234 was generally safe and well tolerated at single doses of 0.2-2.4 mg and after repeated dose administration of up to 2.4 mg q4h for four doses daily for 9 days. The most common treatment-emergent adverse events were mild-to-moderate headaches. There was no evidence of pulmonary irritation or inflammation. Vardenafil was absorbed very rapidly after inhalation as RT234, independent of dose level and number of doses administered. The t_max occurred at the time that the first blood sample following completion of dosing. After C_max was achieved, plasma vardenafil concentrations declined rapidly in an exponential fashion that appeared to be parallel among dose levels. Vardenafil plasma concentrations and PK parameters increased in a dose-proportional manner. Vardenafil systemic exposure was notably greater after oral administration of 20 mg vardenafil tablets (Levitra^®) than after administration of any dose level of RT234. During repeated dose administration of RT234, C_max was attained rapidly following each dose and in a pattern similar to that observed after single-dose administration. Minor accumulation, characterized by very low mean morning predose vardenafil concentrations (<0.5 ng/mL), occurred after q4h dosing of up to four doses per day for 9 days. Taken together, these findings show that no clinically important vardenafil accumulation is likely after repeated-dose administration of RT234. Mean vardenafil t_1/2 values were comparable after single- and repeated-dose administration. Conclusions: Comparative plasma vardenafil bioavailability data from this study provide scientific justification for reliance on Food and Drug Administration findings for Levitra tablets. These findings support further evaluation of RT234 for as-needed treatment of patients with PAH. The Clinical Trials Registration number is ACTRN12618001077257.

01 Feb 2020·Journal of Aerosol Medicine and Pulmonary Drug DeliveryQ4 · MEDICINE

The Confusing World of Dry Powder Inhalers: It Is All About Inspiratory Pressures, Not Inspiratory Flow Rates

Q4 · MEDICINE

Review

Author: Weers, Jeffry G. ; Clark, Andrew R. ; Dhand, Rajiv

Dry powder inhalers (DPIs) all have the ability to aerosolize dry powders, but they each offer different operating mechanisms and resistances to inhaled airflow. This variety has resulted in both clinician and patient confusion concerning DPI performance, use, and effectiveness. Particularly, there is a growing misconception that a single peak inspiratory flow rate (PIFR) can determine a patient's ability to use a DPI effectively, regardless of its design or airflow resistance. For this review article, we have sifted through the relevant literature concerning DPIs, inspiratory pressures, and inspiratory flow rates to provide a comprehensive and concise discussion and recommendations for DPI use. We ultimately clarify that the controlling parameter for DPI performance is not the PIFR but the negative pressure generated by the patient's inspiratory effort. A pressure drop ∼≥1 kPa (∼10 cm H₂O) with any DPI is a reasonable threshold above which a patient should receive an adequate lung dose. Overall, we explore the underlying factors controlling inspiratory pressures, flow rates and dispensing, and dispersion characteristics of the various DPIs to clarify that inspiratory pressures, not flow rates, limit and control a patient's ability to generate sufficient flow for effective DPI use.

01 Jan 2020·Advanced Drug Delivery ReviewsQ1 · MEDICINE

Post-inhalation cough with therapeutic aerosols: Formulation considerations

Q1 · MEDICINE

Review

Author: Sahakijpijarn, Sawittree ; Smyth, Hugh D C ; Weers, Jeffry G ; Miller, Danforth P

This review provides an assessment of post-inhalation cough with therapeutic aerosols. Factors that increase cough may be mitigated through design of the drug, formulation, and device. The incidence of cough is typically less than 5% for drugs with a nominal dose less than 1 mg, including asthma and COPD therapeutics. Cough increases markedly as the dose approaches 100 mg. This is due to changes in the composition of epithelial lining fluid (e.g., increases in osmolality, proton concentration). Whether an individual exhibits cough depends on their degree of sensitization to mechanical and chemical stimuli. Hypersensitivity is increased when the drug, formulation or disease result in increases in lung inflammation. Cough related to changes in epithelial lining fluid composition can be limited by using insoluble neutral forms of drugs and excipients.

100 Deals associated with Respira Therapeutics, Inc.

100 Translational Medicine associated with Respira Therapeutics, Inc.

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