NCT00013715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

August 11, 2008

Status Verified

August 1, 2008

First QC Date

March 28, 2001

Last Update Submit

August 8, 2008

Conditions

Asthma

Keywords

AsthmaRhinovirusOzone

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins School of Hygiene and Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 28, 2001

First Posted

March 30, 2001

Study Start

September 1, 1999

Study Completion

August 1, 2003

Last Updated

August 11, 2008

Record last verified: 2008-08

Locations

US(1)