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Sponsors and Collaborators: |
National Institute of Environmental Health Sciences (NIEHS) Sandler Program for Asthma Research |
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Information provided by: | National Institute of Environmental Health Sciences (NIEHS) |
ClinicalTrials.gov Identifier: | NCT00643058 |
The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide [LPS]) in normal subjects. In this study, we will determine the effect of inhaled endotoxin on exhaled NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol described in this submission will involve the use of NIH Clinical Center Reference Endotoxin which has been approved by the FDA under IND BB-IND-10035.
Condition | Intervention |
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Healthy |
Biological: LPS endotoxin |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Nitric Oxide, LPS and the Pathogenesis of Asthma - Phase II |
Estimated Enrollment: | 100 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sterile Saline, LPS endotoxin
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Biological: LPS endotoxin
Low challenge: saline (diluent), 5000EU, 10,000EU and 20,000EU LPS endotoxin as tolerated High challenge: Saline (diluent), 40,000EU and 80,000EU as tolerated Diluent Challenge: 3 X Sterile saline inhalation (2 ml) |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine M Foss, BSed RRT | (919) 668-3599 | foss0005@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Marc C Levesque, MD, PhD 919-613-7931 marc.levesque@duke.edu | |
Contact: John S Sundy, MD, PhD (919) 668-2169 john.sundy@duke.edu | |
Principal Investigator: Marc C Levesque, MD, PhD |
Principal Investigator: | Marc C Levesque, M.D. PhD | Duke University |
Responsible Party: | Duke University Medical Center ( Marc Levesque M.D. PhD. ) |
Study ID Numbers: | 12496-CP-006B, Pro00005035 |
Study First Received: | March 24, 2008 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00643058 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
LPS endotoxin |
Nitric Oxide Vasodilator Agents Neurotransmitter Agents Antioxidants Anti-Asthmatic Agents |
Asthma Cardiovascular Agents Peripheral Nervous System Agents Healthy Bronchodilator Agents |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Nitric Oxide Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Bronchodilator Agents |