Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic
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|ClinicalTrials.gov Identifier: NCT02111772|
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Biological: Rhinovirus||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic Host|
|Study Start Date :||September 1, 2013|
|Actual Primary Completion Date :||April 20, 2017|
|Actual Study Completion Date :||April 27, 2017|
Experimental: Asthmatic subjects
Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.
Active Comparator: Without Asthma
Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus
- Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection [ Time Frame: 4 days ]The primary endpoint will be based on the comparison of cumulative lower respiratory tract symptom scores (CLRTS) in the asthmatic subjects compared to the non-asthmatic subjects over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath, and cough. Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.
- Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough. [ Time Frame: 4 days ]Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111772
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Heymann W Peter, MD||University of Virginia|