Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus
Status:
Completed
Trial end date:
2017-05-04
Target enrollment:
Participant gender:
Summary
Population surveys have shown a positive correlation between increased levels of total serum
immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that
exacerbations of asthma are frequently triggered by viral respiratory tract infections,
especially those caused by human rhinovirus (RV), also known as the "common cold" virus. This
protocol explores the relationship between rhinovirus and allergen/IgE provoked inflammation.
Experimental challenges with human (RV) result in more persistent upper respiratory tract
symptom scores in asthmatics than in controls. Asthmatics with high levels of IgE also show
greater sensitivity to methacholine and higher levels of expired nitric oxide (eNO) than
those with low levels of IgE. These data suggest that patients with asthma and high levels of
IgE are more likely to have pre-existing inflammation of the airways before virus challenge.
This study is being done to determine whether anti-IgE therapy (with omalizumab) will lead to
a significant decline in inflammatory biomarkers prior to virus inoculation, and thus reduce
the severity of clinical manifestations after an experimental human RV challenge.
Phase:
Phase 2
Details
Lead Sponsor:
University of Virginia
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)