Ozone and Rhinovirus-Induced Disease in Asthmatics

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00013715
• Other study ID #: 9004-CP-001
• Status: Completed
• Phase: N/A
• First received: March 28, 2001
• Last updated: August 8, 2008
• Start date: September 1999
• Est. completion date: August 2003

Study information

• Verified date: August 2008
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	The Johns Hopkins School of Hygiene and Public Health	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States,