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Ozone and Rhinovirus-Induced Disease in Asthmatics

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ClinicalTrials.gov Identifier: NCT00013715
Recruitment Status : Completed
First Posted : March 30, 2001
Last Update Posted : August 11, 2008
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

Brief Summary:
In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper respiratory infections. Despite evidence that environmental oxidant pollutants, such as ozone, may increase the severity of viral disease, the mechanisms underlying such an effect have not been identified. This study will test the hypothesis that exposure of allergic asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing infectivity and intensifying virus-induced inflammation.

Condition or disease
Asthma

Detailed Description:
In mild asthmatics, the study will investigate: (1) if exposure to ozone will enhance the viral infective process in the nasal epithelium, (2) the effect of ozone exposure on RV-induced inflammatory gene expression, mediator release and inflammatory cell influx into the upper and lower airways, and (3) the interactive effects of ozone and RV on airway reactivity. This information will improve our understanding of the risk associated with oxidant pollutant exposure in this population of individuals in whom RV infection may represent a significant health concern.

Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Study Start Date : September 1999
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Ozone
U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Subjects recruited will be non-asthmatic controls or mild allergic asthmatics using beta-agonists, mostly on an "as needed" basis. Selection criteria will include good general health by medical history and physical examination, no history of smoking, and the absence of respiratory infection in the preceding 6 week period. Subjects will undergo serologic testing and must have a negative test for neutralizing antibodies to RV16 to participate in all but one study of the project.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013715


Locations
United States, Maryland
The Johns Hopkins School of Hygiene and Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)

ClinicalTrials.gov Identifier: NCT00013715     History of Changes
Other Study ID Numbers: 9004-CP-001
First Posted: March 30, 2001    Key Record Dates
Last Update Posted: August 11, 2008
Last Verified: August 2008

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Asthma
Rhinovirus
Ozone