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Tracking Information | |
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First Received Date † | March 28, 2001 |
Last Updated Date | August 8, 2008 |
Start Date † | September 1999 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00013715 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Ozone and Rhinovirus-Induced Disease in Asthmatics |
Official Title † | |
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. |
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 Phase | |
Study Type † | Observational |
Study Design † | Prospective |
Condition † | Asthma |
Intervention † | |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 60 |
Completion Date | August 2003 |
Primary Completion Date | |
Eligibility 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. |
Gender | Both |
Ages | 18 Years to 45 Years |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00013715 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | National Institute of Environmental Health Sciences (NIEHS) |
Collaborators †† | |
Investigators † | |
Information Provided By | National Institute of Environmental Health Sciences (NIEHS) |
Verification Date | August 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |