Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic
Condition: Asthma
MeSH terms: Infections; Asthma
Study type: Interventional

Summary: 
      In patients with asthma, reactions to allergens in the environment (such as mold, pollen,
      weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms.
      However, upper respiratory tract infections, typically those caused by the common cold virus,
      rhinovirus, can also cause asthma to get worse. In previous studies at the University of
      Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody
      (called IgE) in their blood, developed more persistent cold and chest symptoms when they were
      given an infection with rhinovirus (the most frequent cause of the common cold). The cold
      symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold. These
      symptoms, including nasal congestion, are similar to what you have experienced with previous
      colds.

      This study is being done to learn how a common cold caused by a viral infection affects
      people with asthma. The goal is to learn how to improve the care of asthma symptoms caused by
      the common cold virus (called rhinovirus). Most adults experience one or two colds caused by
      rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral infections
      are caused by this virus, primarily in children. Adults are less likely to experience
      significant changes in their asthma symptoms when they get colds, because they have developed
      protective immune responses from previous colds which help diminish symptoms.
    

Detailed description: 
      Using rhinovirus strain 16 (RV-16) for inoculation, this study is designed to examine
      mechanisms of the asthmatic response to RV in the atopic host. In keeping with this, the
      primary objective of this investigation will be to test the hypothesis that mild asthmatics
      enrolled in this study will experience significantly increased lower respiratory tract
      symptoms over the first 4 days after experimental inoculation with RV-16 than non-allergic,
      non-asthmatic controls (as shown in our previous studies). It is anticipated that the results
      will serve to guide the development of new treatments to prevent asthma attacks provoked by
      RV. This will be a 5 week longitudinal study of 18 young allergic adults with mild asthma and
      18 non-asthmatic controls who will be evaluated for 1 week to establish baseline symptoms and
      lung function, followed by an inoculation with rhinovirus (strain-16) and subsequent clinical
      and laboratory (mechanistic) monitoring for an additional 4 weeks. To participate in this
      study, subjects must live within 90 minutes by car from the University of Virginia.

      Note: This study has been reviewed and is being monitored for safety by the NIH/NIAID Safety
      Monitoring Committee and by teh University of Virginia IRB (#12673). The virus pool used for
      inoculation has been produced under GMP conditions and is approved for this research by the
      FDA.
    

Intervention name(s): Rhinovirus
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mild asthma, rhinovirus, young adults