Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.
- Conditions
- Pulmonary Arterial HypertensionIdiopathic Pulmonary Fibrosis
- Interventions
- Drug: Inhaled Nitric Oxide
- Registration Number
- NCT01265888
- Lead Sponsor
- Geno LLC
- Brief Summary
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.
- Detailed Description
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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dosing Group 3 Inhaled Nitric Oxide 4 LPM of inhaled nitric oxide via nasal cannula: approximately 20 ppm Dosing Group 1 Inhaled Nitric Oxide 1 Liter per Minute (LPM)of inhaled nitric oxide via nasal cannula: approximately 5 parts per million (ppm) Dosing Group 2 Inhaled Nitric Oxide 2 LPM of inhaled nitric oxide via nasal cannula: approximately 15 ppm
- Primary Outcome Measures
Name Time Method Identify the minimally and maximum effective doses of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo. through end of Right Heart Catheterization procedure (Treatment Phase approximately 3 hours) 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.
- Secondary Outcome Measures
Name Time Method Evaluate the pharmacokinetics of total nitrates/nitrites and methemoglobin produced following inhalation of nitric oxide via the GeNOsyl® System. up through 24 hrs after treatment period for subjects participating in PK sub-study Individual pharmacokinetic parameters for total nitrates/nitrites and methemoglobin will be summarized with descriptive characteristics.
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. through end of study (approximately 30 days after treatment visit)
Trial Locations
- Locations (10)
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Ohio State University, Martha Morehouse Medical Plaza
🇺🇸Columbus, Ohio, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
University of Alabama @ Birmingham
🇺🇸Birmingham, Alabama, United States
University of California- Davis Medical Center
🇺🇸Sacramento, California, United States
VA Greater LA Health Care System-UCLA
🇺🇸Los Angeles, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States