Protocol Details

Effects of Inhaled Carbon Monoxide on Pulmonary Inflammatory Responses Following Endotoxin Instillation

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	05-CC-0012
Sponsoring Institute	National Institutes of Health Clinical Center (CC)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: 40
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Lung Permeability; Endotoxin Tolerance; Bronchoscopy; Carbon Monoxide Inhalation
Recruitment Keyword(s)	None
Condition(s)	Respiratory Distress Syndrome, Adult
Investigational Drug(s)	Endotoxin Carbon Monoxide
Investigational Device(s)	None
Intervention(s)	Procedure/Surgery: Bronchoscopy Procedure/Surgery: Bronchoalveolar lavage Drug: Endotoxin Drug: Carbon Monoxide
Supporting Site	NIH Clinical Center

This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or patients who develop serious blood stream infections. Studies in the laboratory and in animals show that CO can decrease lung inflammation.

Healthy volunteers between 18 and 40 years of age who do not smoke, are not taking any medications, do not have asthma, are not allergic to sulfa- and penicillin-based drugs, and are not pregnant may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), and chest x-ray. Subjects are enrolled in either a pilot study or the main study.

Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of endotoxin (a component of bacteria that causes inflammation similar to that in patients with lung infections) on lung function. Before the procedure, a small plastic tube (catheter) is placed in a vein to collect blood samples and another is placed in an artery to check blood pressure. For the bronchoscopy, the mouth and nasal airways are numbed with lidocaine, and a bronchoscope (thin flexible tube) is passed through the nose into the airways of the lung. A small amount of salt water is squirted through the bronchoscope into one lung and then salt water containing endotoxin is squirted into the other lung.

Following the bronchoscopy, subjects are treated with either CO or room air (placebo) for 6 hours. (Subjects in the pilot study receive treatment for only 3 hours). The gas is delivered through a cushioned mask placed over the nose and mouth. The amount of exhaled CO is measured before, during, and after inhalation of the gas. For this measurement, subjects take a deep breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring device until they feel their lungs are empty.

After the CO treatment, a second bronchoscopy is done to examine how the lung responded to the CO or room air. This is studied in two ways. To sample the air, a large needle is used to withdraw air through the bronchoscope over about 3 seconds. Then the areas of the lung that were squirted with salt water alone and with endotoxin and salt water and are rinsed (lavage) and cells and secretions are collected.

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Eligibility

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

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Citations:

Hudson LD, Milberg JA, Anardi D, Maunder RJ. Clinical risks for development of the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):293-301.

Baumann WR, et al. Incidence and mortality of adult respiratory distress syndrome: a prospective analysis from a large metropolitan hospital. Crit Care Med. 1986 Jan;14(1):1-4.

Milberg JA, Davis DR, Steinberg KP, Hudson LD. Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983-1993. JAMA. 1995 Jan 25;273(4):306-9.

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Anthony F. Suffredini, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1C118 10 Center Drive, MSC 1156 Bethesda, Maryland 20892-1156 (301) 435-8727 mdanis@mail.nih.gov	Anthony F. Suffredini, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1C118 10 Center Drive, MSC 1156 Bethesda, Maryland 20892-1156 (240) 353-7238 mdanis@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00094406

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