Ozone and Rhinovirus-Induced Disease in Asthmatics

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00013715
First received: March 28, 2001
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

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
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 60
Study Start Date: September 1999
Estimated Study Completion Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013715

Locations
United States, Maryland
The Johns Hopkins School of Hygiene and Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00013715     History of Changes
Other Study ID Numbers: 9004-CP-001
Study First Received: March 28, 2001
Last Updated: August 8, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014