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

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ClinicalTrials.gov Identifier: NCT04266197
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : October 31, 2022
Information provided by (Responsible Party):
Respira Therapeutics, Inc.

Brief Summary:
The objectives of this study are to evaluate the effects of RT234 on exercise parameters assessed by a specialized exercise test (Cardiopulmonary Exercise Test or CPET) in patients with pulmonary arterial hypertension (PAH).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) Phase 2

Detailed Description:
Consequences of PAH are significant limitations in cardiorespiratory fitness (CRF), exercise capacity, and profound dyspnea with physical exertion. The objective of this study is to assess the ability of a single inhaled dose of RT234 to acutely improve primary CPET measures of CRF and exercise capacity, and to lower the sensation of dyspnea with physical exertion compared to baseline CPET measures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Arm Intervention/treatment
Experimental: RT234 0.5 mg Cohort 1
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 capsules of a dry powder formulation containing vardenafil administered via oral inhalation with a non-invasive AOS DPI.
Other Name: inhaled vardenafil

Experimental: RT234 1.0 mg Cohort 2
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 capsules of a dry powder formulation containing vardenafil administered via oral inhalation with a non-invasive AOS DPI.
Other Name: inhaled vardenafil

Primary Outcome Measures :
  1. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From baseline to follow-up day 15 post-treatment ]
    TEAEs as grouped by MedDRA system organ class and relationship to treatment.

  2. Change in Vital Signs [ Time Frame: From baseline to follow-up day 15 post-treatment ]
    This variable will include mean arterial blood pressure expressed in mmHg (calculated utilizing recorded systolic and diastolic blood pressures in mmHg).

  3. Change in peak oxygen consumption (VO2) assessed by CPET [ Time Frame: From baseline to 15 minutes post-treatment ]
    This variable will be assessed by ventilatory expired gas analysis during exercise testing and will be expressed in ml/ kg/min. Mean values from baseline to post-treatment will be compared.

Secondary Outcome Measures :
  1. Change in 6-minute walk distance (6MWD) [ Time Frame: From baseline to 15 minutes post-treatment ]
    Change from mean Screening in 6MWD when 6-minute walk test (6MWT) is performed 15 minutes post-RT234 dosing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Ages 18 and 80 years, inclusive.
  2. Diagnosis of Right Heart Catheterization (RHC)-confirmed WHO Group 1 PAH in any of the following 3 categories:

    1. Idiopathic, primary, or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH) OR
    2. 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
    3. PAH associated with: i. Human immunodeficiency virus (HIV) infection with no evidence of opportunistic infection in the preceding 6 months; ii. Simple, congenital systemic-to-pulmonary shunts at least 1-year post-surgical repair; iii. Exposure to legal drugs, chemicals and toxins, such as fenfluramine, derivatives, other anorexigens, toxic rapeseed oil, or L-tryptophan.
  3. The patient must have had a ventilation/perfusion (V/Q) scan, computerized tomography angiogram, or pulmonary arteriogram that rules out chronic thromboembolic pulmonary hypertension (CTEPH).
  4. Previous diagnosis with PAH, but with the following conditions:

    1. Stable PAH without significant adjustments of disease-specific background PAH therapy, at least 3 months prior to the 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 within 1 month of Screening.


    2. 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.
  5. PFT within 6 months prior to the baseline CPET.
  6. Has had RHC performed prior to Screening which is consistent with the diagnosis of PAH.
  7. Has WHO/NYHA functional class II-IV symptomatology.
  8. On stable oral PAH disease-specific background therapy of up to 3 oral therapies (any combination of an ERA, PDE5 inhibitor, and/or a prostacyclin or prostacyclin receptor agonist) and/or inhaled therapy. 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 within 1 month of Screening.
  9. Must be able to walk a distance of at least 150 meters on the 6MWT. This will be determined using the mean of the two 6MWT results done between Visits 1 and 2.
  10. If the subject is taking the following concomitant medications which may affect PAH, the subject must be on a stable therapeutic dose for at least 1 month prior to the start of Screening and the dosage maintained throughout the study.

    1. Vasodilators
    2. Anticoagulants

Exclusion Criteria:

  1. Baseline systemic hypotension defined as MAP < 50 mmHg or SBP < 90 mmHg at Screening.
  2. History of chronic uncontrolled asthma.
  3. Requirement of intravenous inotropes therapies within 30 days prior to the baseline CPET procedure.
  4. Use of PAH medications that are not taken by mouth.
  5. Use of oral, topical, or inhaled nitrates within 2 weeks prior to the baseline CPET procedure.
  6. Has uncontrolled systemic hypertension
  7. 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 allowed.
  8. Evidence or history of left-sided heart disease and/or clinically significant cardiac disease.
  9. History of atrial septostomy.
  10. History of known uncorrected right-to-left shunt, clinically significant persistently patent foramen ovale, or known Eisenmenger's physiology.
  11. Paroxysmal or uncontrolled atrial fibrillation.
  12. Diagnosis of Down syndrome.
  13. 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.
  14. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is ≥3 x the upper limit of the normal range.
  15. Platelets below 50,000/μL at Screening.
  16. Hemoglobin (Hgb) concentration < 9 g/dL at Screening.
  17. For subjects with HIV-associated PAH, any of the following:

    1. Concomitant active opportunistic infections within 6 months prior to Screening;
    2. Detectable viral load within 3 months of Screening;
    3. CD4+ T-cell count < 200/mm^3 within 3 months prior to Screening;
    4. Changes in antiretroviral regimen within 3 months prior to Screening.
  18. Malignancy within 5 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.
  19. History of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions.
  20. Vision loss due to non-arteritic anterior ischemic optic neuropathy or other optic perfusion impairment.
  21. History of sudden sensorineural hearing loss.
  22. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) > 450 msec and female subjects with QTcF > 470 msec on electrocardiogram (ECG) measured at Screening.
  23. Participation in a drug, device, or other interventional clinical study, other than post-marketing observational extension study, within 30 days prior to Screening.
  24. Participation in the active phase (other than the maintenance phase) of a pulmonary rehabilitation/structured exercise training program within 6 months prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266197

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Contact: Donna Jarlenski, MS 650-436-4083 djarlenski@respiratherapeutics.com

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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Sarah Huston       scarlson@uabmc.edu   
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90024
Contact: Lloyd Liang       llliang@mednet.ucla.edu   
UC Davis Recruiting
Sacramento, California, United States, 95618
Contact: Cynthia Perry       clpbaker@ucdavis.edu   
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jacqueline Furrier    415-476-4922    Jacqueline.Furrier@ucsf.edu   
United States, Georgia
Accel Clinical Research/Atlanta Clinical Research Centers Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sue Shin       Sue.shin@atlantaclinicalresearch.com   
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Reeya Patel       rpatel6@augusta.edu   
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Vanita Patel       vpatel4@bsd.uchicago.edu   
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Luigi Boccardi    913-588-6045    lboccardi@kumc.edu   
United States, Louisiana
Ochsner Louisiana State University Health Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Nathan Glassy       Nathaniel.glassy@lsuhs.edu   
United States, Massachusetts
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Bipin Malla       bmalla@tuftsmedicalcenter.org   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ellen Lovato       elovato@wustl.edu   
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Lisa Roberston       lirobertson@salud.unm.edu   
United States, Ohio
University Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Valerie Walker    216-844-2479    Valerie.Walker@UHhospitals.org   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Joseph Santiago    614-366-4756    Joseph.santiago@osumc.edu   
United States, Texas
Baylor Scott & White Medical Center Recruiting
Temple, Texas, United States, 76508
Contact: Richard Vargus       Richard.Vargas@BSWHealth.org   
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Contact: Amy Frayser    804-216-0630    amy.frayser@vcuhealth.org   
Sponsors and Collaborators
Respira Therapeutics, Inc.
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Study Chair: Carol Ann Satler, MD, PhD Respira Therapeutics, Inc.
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Responsible Party: Respira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04266197    
Other Study ID Numbers: RT234-PAH-CL202
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Respira Therapeutics, Inc.:
Cardiopulmonary Exercise Test
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents