: Nitric Oxide for inhalation at 800ppm, plus 100% O2, to be used to assess pulmonary vaso reactivity during Pulmonary Vasodilator Testing
Conditions
Interventions
Trade Name: INOmax® 400ppm mol/mol
Inhalation gas
(same active, different strength)
Product Name: INOmax® 800ppm mol/mol
Product Code: N/A
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Nitr
Sponsors
INO Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must meet the following criteria: 1. Have any one of the three disease categories: a. Idiopathic Pulmonary Arterial Hypertension i. PAPm › 25mmHg at rest, PCWP = 15mmHg, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization. b. CHD with pulmonary hypertension repaired and unrepaired, i. PAPm › 25mmHg at rest, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization c. Cardiomyopathy i. PAPm › 25mmHg at rest, and PVRI › 3 u•m2 or diagnosed clinically with no previous catheterization. 2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing. 3. Males or females, ages 4 weeks to 18 years, inclusive 4. Signed IRB/IEC approved informed consent (and assent if applicable). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient will be excluded from enrolment if any of the following are true: 1. Focal pulmonary infiltrates on chest radiograph. 2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient’s pulmonary hypertension. 3. Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, or are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other PDE-5 inhibitors, or prostacyclin. 4. Pregnant (urine HCG +).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : The primary objective of the trial is to compare the number of patients with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen. ;Secondary Objective: Secondary objectives : The additional objectives of the trial are to compare the incidence and types of drug related and serious adverse events as well as the number of patients with reversible pulmonary hypertension due to nitric oxide for inhalation alone compared to 100% oxygen and to oxygen with nitric oxide for inhalation ;Primary end point(s): The criteria for response are: Patients with Idiopathic Pulmonary Arterial Hypertension or patients with CHD who do not have an unrestricted shunt at the level of the ventricle or ductus arterosus, response will be defined as: 1) a decrease in PAPm = 20% and no decrease in cardiac index (within 5%) Patients with cardiomyopathy or patients who have an unrestricted shunt at the level of the ventricle or ductus arterosus, response will be defined as: 1) a decrease in PAPm = 20% and no decrease in cardiac index (within 5%) or 2) a decrease in PVRI = 25% and no decrease in cardiac index (within 5%) | — |
Countries
Spain, United Kingdom
Outcome results
None listed