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Generated: December 14, 2018

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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 Summary
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nitric Oxide

Condition Name

Condition Name for Nitric Oxide
Intervention Trials
Asthma 52
Pulmonary Hypertension 37
Hypertension 26
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Condition MeSH

Condition MeSH for Nitric Oxide
Intervention Trials
Hypertension 99
Hypertension, Pulmonary 64
Asthma 48
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Clinical Trial Locations for Nitric Oxide

Trials by Country

Trials by Country for Nitric Oxide
Location Trials
United States 797
Canada 63
United Kingdom 59
Germany 45
Italy 36
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Trials by US State

Trials by US State for Nitric Oxide
Location Trials
California 67
Maryland 50
Texas 46
New York 43
Massachusetts 38
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Clinical Trial Progress for Nitric Oxide

Clinical Trial Phase

Clinical Trial Phase for Nitric Oxide
Clinical Trial Phase Trials
Phase 4 146
Phase 3 96
Phase 2/Phase 3 42
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Clinical Trial Status

Clinical Trial Status for Nitric Oxide
Clinical Trial Phase Trials
Completed 380
Recruiting 109
Unknown status 76
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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) 47
Mallinckrodt 38
National Institutes of Health (NIH) 14
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Sponsor Type

Sponsor Type for Nitric Oxide
Sponsor Trials
Other 851
Industry 220
NIH 110
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Covington
Medtronic
Citi
Boehringer Ingelheim
Accenture
Chinese Patent Office
US Department of Justice
Cerilliant

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