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临床试验/NCT02111772
NCT02111772已完成不适用

Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic Host

University of Virginia2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Asthmatic subjects

Experimental

Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.

干预措施: Rhinovirus (Biological)

Without Asthma

Active Comparator

Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus

干预措施: Rhinovirus (Biological)

结局指标

主要结局

Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection

时间窗: 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.

次要结局

  • Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough.(4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Heymann, MD

Head Pediatric Allergy and Immunology

University of Virginia

研究点 (2)

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