CLINICAL TRIALS PROFILE FOR INOMAX

All Clinical Trials for Inomax

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00041548 ↗	Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation	Terminated	Mallinckrodt	Phase 1/Phase 2	2002-05-01	The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
NCT00041574 ↗	Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide	Terminated	Mallinckrodt	Phase 2	2002-04-01	The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
NCT00060840 ↗	The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation	Completed	Mallinckrodt	Phase 2	2003-07-01	The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	Mallinckrodt	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
NCT00608322 ↗	Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis	Completed	National Institute of General Medical Sciences (NIGMS)	Phase 3	2009-08-01	The purpose of this study is to determine whether inhaled nitric oxide is an effective treatment for microcirculatory dysfunction and acute organ system failure in the early stage of sepsis therapy.

Clinical Trial Conditions for Inomax

Condition Name

Condition Name for Inomax
Intervention	Trials
Lung Disease	2
Sickle Cell Disease	2
Hypoxemia	1
Pulmonary Embolism	1

Condition MeSH

Condition MeSH for Inomax
Intervention	Trials
Anemia, Sickle Cell	3
Hypertension, Pulmonary	3
Lung Diseases	2
Hypoxia	2

Clinical Trial Locations for Inomax

Trials by Country

Trials by Country for Inomax
Location	Trials
United States	44
Canada	3
Germany	2
United Kingdom	1
Spain	1

Trials by US State

Trials by US State for Inomax
Location	Trials
California	4
New Jersey	3
Colorado	3
Ohio	3
North Carolina	2

Clinical Trial Progress for Inomax

Clinical Trial Phase

Clinical Trial Phase for Inomax
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Inomax
Clinical Trial Phase	Trials
Completed	7
Terminated	4
Withdrawn	2

Clinical Trial Sponsors for Inomax

Sponsor Name

Sponsor Name for Inomax
Sponsor	Trials
Mallinckrodt	11
University of Colorado, Denver	1
Assistance Publique - Hôpitaux de Paris	1

Sponsor Type

Sponsor Type for Inomax
Sponsor	Trials
Industry	11
Other	10
NIH	2