A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.
Up to 54 subjects undergoing RHC are planned in this study, and shall include subjects meeting eligibility criteria classified as WHO Group 1 PAH or WHO Group 3 IPF-PH. Subjects will receive inhaled nitric oxide from the GeNOsyl® System to characterize the hemodynamic response and evaluate safety and tolerability. Dose cohorts of approximately 5, 15, and 20 ppm nitric oxide in air will be studied. Different dose levels will be achieved by varying the flow rate of the drug substance (80 ppm NO2 in balance air) delivered to the subject via nasal cannula. Each subject will receive two different doses of inhaled nitric oxide separated by a placebo (medical grade air or supplemental oxygen) washout. Eligible subjects will be assigned to a dosing cohort in an escalating manner to receive study drug (80 ppm nitric oxide in air.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM
Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 2 LPM
Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 4 LPM
University of Alabama @ Birmingham
Birmingham, Alabama, United States
VA Greater LA Health Care System-UCLA
Los Angeles, California, United States
University of California- Davis Medical Center
Sacramento, California, United States
Identify the minimally and maximum effective doses of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.
Assess mean change in pulmonary vascular resistance (PVR) for study drug dose 2 compared to placebo. Assess change from pre-dose to end-of-hemodynamic assessment for study drug dose 1. Assess change from placebo to end-of-hemodynamic assessment for study drug dose 2.
Time frame: through end of Right Heart Catheterization procedure (Treatment Phase approximately 3 hours)
Assess the safety and tolerability of nitric oxide generated by the GeNOsyl® System in subjects with WHO Group 1 PAH and WHO Group 3 PH-IPF.
Time frame: through end of study (approximately 30 days after treatment visit)
Evaluate the pharmacokinetics of total nitrates/nitrites and methemoglobin produced following inhalation of nitric oxide via the GeNOsyl® System.
Individual pharmacokinetic parameters for total nitrates/nitrites and methemoglobin will be summarized with descriptive characteristics.
Time frame: up through 24 hrs after treatment period for subjects participating in PK sub-study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
National Jewish Health
Denver, Colorado, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Ohio State University, Martha Morehouse Medical Plaza
Columbus, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States