Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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).

Key facts

Study ID

NCT04266197

Run by

Respira Therapeutics, Inc.

People needed

42

Starts

2020-09-25

Expected to finish

2025-01-07

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be between 18 and 80 years of age, inclusive.
• Must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to undergoing any research-related procedures.
• Must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Able to exercise during CPET and ambulate independently.
• Diagnosis documented and confirmed by Right Heart Catheterization (RHC)-confirmed WHO Group 1 PAH in any of the following 3 categories:
• Idiopathic, primary, or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH) OR
• PAH associated with one of the following connective tissue diseases:
• i) Systemic sclerosis (scleroderma) ii) Limited scleroderma iii) Mixed connective tissue disease iv) Systemic lupus erythematosus v) Overlap syndrome vi) Other autoimmune disorders OR c) PAH associated with: i) Human immunodeficiency virus (HIV) infection. ii) Simple, congenital systemic-to-pulmonary shunts at least 1-year post-surgical repair.
• iii) Exposure to drugs, chemicals, and toxins, such as fenfluramine derivatives, other anorexigens, toxic rapeseed oil, or L-tryptophan.
• Subjects with a diagnosis of HIV must have stable disease, defined by:
• Unchanged medication treatment regimen for HIV for at least 8 weeks prior to beginning Visit 1 Screen assessments.
• No active opportunistic infection during the Screening Period.
• No hospitalizations for HIV for at least 4 weeks prior to beginning Visit 1 Screen assessments.
• The patient must have adequate, documented test results that exclude chronic thromboembolic pulmonary hypertension (CTEPH).
• Previous diagnosis of PAH, but with the following conditions:
• Stable PAH without significant adjustments of disease-specific background PAH therapy, at least 3 months prior to the Baseline CPET procedure. Stable is defined as no change in PAH -specific drug therapy within 3 months of Screening Visit 1, and for the duration of the study, and no change in dose of PAH-specific drug(s) within 1 month of Screening.
• AND
• If on corticosteroids, has been receiving a stable dose of ≤ 20 mg/day of prednisone (or equivalent dose of other corticosteroid) for at least 30 days prior to the Baseline CPET.
• PFT within 6 months prior to signing the Informed Consent Form that fulfills the following criteria:
• FEV1 ≥ 60% predicted (pre-bronchodilators).
• FEV1 / FVC ≥ 60% (pre-bronchodilators).
• FVC ≥ 60% predicted.
• Has had RHC performed and documented prior to Screening that meets the following hemodynamic criteria:
• mPAP ≥ 20 mmHg.
• PVR ≥ 300 dyn·s/cm5.

You may not qualify if…

• Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
• Baseline systemic hypotension defined as mean arterial pressure (MAP) \< 50 mmHg or SBP \< 90 mmHg at Screening.
• History of chronic uncontrolled asthma; subjects with inability to use, or may have potential difficulties using, an inhaler device.
• Use of continuous, supplemental oxygen. Subject must be able to complete exercise tests without the use of supplemental oxygen.
• NOTE: Use of nocturnal oxygen is acceptable.
• Requirement of intravenous inotropic therapies within 30 days prior to the Baseline CPET procedure.
• Use of riociguat (Adempas®) as background PAH therapy as of 1 month prior to initiating Screening or during the study through the end of Visit 4.
• Use of oral, topical, or inhaled nitrates within 2 weeks prior to the Baseline CPET procedure.
• Has history of uncontrolled systemic hypertension as evidenced by sitting SBP \> 175 mmHg or sitting diastolic blood pressure (DBP) \> 110 mmHg at Screening.
• Portopulmonary hypertension, portal hypertension, or chronic liver disease determined to be Child-Pugh B or C, including hepatitis B virus and/or hepatitis C virus (HCV). Subjects who have had a previous infection with HCV and who have a negative viral load after receiving a course of curative treatment are
• Subjects who have 3 or more of the following left ventricular disease/dysfunction risk factors are not eligible:
• Hypertension requiring medication therapy.
• Diabetes mellitus - any type.
• History of significant coronary artery disease (CAD) established by any one of the following:
• i) Myocardial infarction within 12 months of screening ii) Percutaneous coronary intervention within 12 months of screening iii) Angiographic evidence of CAD (\> 50% stenosis in at least 1 vessel) either by invasive angiography or by CT angiography.
• iv) Positive stress test imaging, either pharmacologic or with exercise. v) Previous coronary artery surgery. vi) Chronic stable angina.
• Uncorrected right-to-left shunt, clinically relevant persistently patent foramen ovale in the judgement of the Investigator or known Eisenmenger's physiology.
• Paroxysmal or uncontrolled atrial fibrillation (defined as a resting heart rate greater than or equal to 110 bpm).
• Chronic renal insufficiency as defined by serum creatinine \> 2.5 mg/dL or has an estimated glomerular filtration rate (eGFR) \< 30 mL/min utilizing the Modification of Diet in Renal Disease (MDRD) Study equation at Screening or requires dialytic support.
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is ≥ 3x the upper limit of the normal range.
• Platelets below 50,000/μL at Screening.
• Hemoglobin (Hgb) concentration \< 9 g/dL at Screening.
• Malignancy within 2 years prior to Screening with the exception of localized non-metastatic basal cell carcinoma of the skin and in-situ carcinoma of the cervix excised with curative intent.
• Recent history (within 6 months prior to Screening) of, or current alcohol or drug/solvent use disorder as assessed by the Investigator.
• Known hypersensitivity to active drug substance (vardenafil) or drugs of the same class, or any excipients of the drug formulation(s).

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• UCLA — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• UC Davis — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• MedStar Heart and Vascular Institute — Washington D.C., District of Columbia, United States
• Augusta University — Augusta, Georgia, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Health — Louisville, Kentucky, United States
• Ochsner Louisiana State University Health — Shreveport, Louisiana, United States
• Tufts University — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Mount Sinai Hospital — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University Hospital — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Ascension Seton Medical Center Austin — Austin, Texas, United States
• Baylor Scott and White Institute — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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