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Last Updated: October 20, 2019

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CLINICAL TRIALS PROFILE FOR NITRIC OXIDE

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Clinical Trials for Nitric Oxide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00001303 Effects of Endotoxin in Normal Human Volunteers Completed National Institutes of Health Clinical Center (CC) Phase 1 1992-04-01 Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts to humans, even though it is not an infection, it triggers a set of responses that are typical of what one would see with a true bacterial infection. This allows us to study the earliest changes in molecules and cells that are involved in some bacterial infections. This type of model is safe and has been used in humans for many years to understand the body s responses during infections. Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen for asymptomatic coronary artery disease. Participants will undergo one or more of the following procedures: Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal Biopsies: These techniques for examining lung function are used routinely in patient care and clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large airways of the lung. Cells and secretions from the airways are rinsed with salt water (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the ball of a ballpoint pen) lining the airways are removed for examination under the microscope. Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14 days to analyze the body s immune response to the bacteria in the blood. Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted through a bronchoscope into a lobe of one lung, and then salt water containing a small dose of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see above) are then done to study the response of the lung to the endotoxin. In addition, air is withdrawn through the bronchoscope to study air components from the lung that was instilled with salt water or endotoxin. Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per million, is given through a cushioned mask placed over the mouth and nose. (Some participants will be given the nitric oxide mixture and others will breathe only room air through the mask to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and biopsy. Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples. First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the artery, the catheter is slipped over the needle into the vessel, and the needle is removed.
NCT00001716 Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia Completed National Institutes of Health Clinical Center (CC) Phase 2 1998-07-01 Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels and cause pain and injury to organs. Some of the complications caused by the sticking of blood cells are called acute pain crisis and acute chest syndrome (ACS). Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle cell hemoglobin molecules, thereby improving blood flow through small vessels. This study is designed to evaluate the effects of NO, when taken in combination with a drug called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects of these two drugs only last while the patient is receiving them. Researchers hope the information learned from this study will help to develop new therapies for sickle cell anemia.
NCT00001752 Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1998-09-01 Estrogen therapy has been associated with reduced risk of coronary heart disease events in observational studies of postmenopausal women. Although favorable effects of estrogen on lipoprotein cholesterol levels probably account for much of this benefit, direct vascular effects (vasomotor, hemostatic, anti-inflammatory) regulated by nitric oxide (NO) may also be of importance. We have recently shown that vasodilator effects of estrogen in the coronary circulation are due to enhanced bioactivity of NO released from the endothelium. Estrogen has been shown to stimulate synthesis and activity of the enzyme NO synthase with enhanced NO synthesis in endothelial cells in culture. Because L-arginine is the natural substrate for the enzyme NO synthase, we propose that the combination of L-arginine and estrogen might have additive vasomotor, hemostatic and anti-inflammatory effects in hypercholesterolemic postmenopausal women.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nitric Oxide

Condition Name

Condition Name for Nitric Oxide
Intervention Trials
Asthma 54
Pulmonary Hypertension 38
Hypertension 28
Sickle Cell Disease 22
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Condition MeSH

Condition MeSH for Nitric Oxide
Intervention Trials
Hypertension 103
Hypertension, Pulmonary 66
Asthma 49
Anemia, Sickle Cell 33
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Clinical Trial Locations for Nitric Oxide

Trials by Country

Trials by Country for Nitric Oxide
Location Trials
United States 829
United Kingdom 65
Canada 64
Germany 45
Italy 37
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Trials by US State

Trials by US State for Nitric Oxide
Location Trials
California 68
Texas 54
Maryland 51
New York 46
Massachusetts 41
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Clinical Trial Progress for Nitric Oxide

Clinical Trial Phase

Clinical Trial Phase for Nitric Oxide
Clinical Trial Phase Trials
Phase 4 152
Phase 3 100
Phase 2/Phase 3 45
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Clinical Trial Status

Clinical Trial Status for Nitric Oxide
Clinical Trial Phase Trials
Completed 386
Recruiting 125
Not yet recruiting 81
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Clinical Trial Sponsors for Nitric Oxide

Sponsor Name

Sponsor Name for Nitric Oxide
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 49
Mallinckrodt 39
National Institutes of Health (NIH) 15
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Sponsor Type

Sponsor Type for Nitric Oxide
Sponsor Trials
Other 914
Industry 227
NIH 113
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