Early Antiviral Responses to Rhinovirus Infection in Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Nasal IFN-λ at 6 hours post rhinovirus infection
研究概览
简要总结
The bulk of the morbidity and mortality related to asthma is during periods of acutely increased symptomatology called 'exacerbations'. Roughly half of asthma sufferers experience such an exacerbation each year. Most of these events are triggered by viral infections, usually the common cold virus (rhinovirus).
A key part of the body's defence against viral infections is to produce antiviral proteins called 'interferons', which have a myriad of effects to stop viruses. Previous work on cells taken from volunteers with asthma and healthy controls and infected with rhinovirus in the lab suggests interferon production is impaired in asthma. However when human volunteers with asthma are infected with rhinovirus, high levels of interferon are found a few days later - along with high numbers of virus. Whether the high virus numbers are the result of an initially weak interferon response, with subsequently unchecked viral replication leading to exaggerated interferon levels, is unknown as no one has measured interferons early in infection.
By infecting volunteers with asthma and healthy controls with rhinovirus at a known time, only done in a handful of centres worldwide, we will be able to measure interferons within hours of infection and well before symptoms develop.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55 years
- •Doctor diagnosis of asthma
- •Previous asthma exacerbation
排除标准
- •Smoking history over past 12 months
- •Sinonasal disease, including current symptoms of allergic rhinitis
- •Asthma exacerbation or an upper respiratory viral infection within the previous six weeks
- •Current or concomitant use of oral steroids, monoclonal antibodies or nasal sprays
- •Neutralising antibodies to rhinovirus (RV)-16
- •Clinically significant diseases other than asthma which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, influence the results of the study, an/or the patient's ability to take part in it
- •Inability to understand written or verbal information in English
- •For healthy control group:
- •Inclusion Criteria:
- •Age 18-55 years
- •Exclusion Criteria:
- •As for Asthma group and in addition:
- •History of asthma
结局指标
主要结局
Nasal IFN-λ at 6 hours post rhinovirus infection
时间窗: 6 hours
Difference in IFN-λ in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls
次要结局
- Nasal IFN-λ at 3 hours post rhinovirus infection(3 hours)
- Nasal IFN-λ at 24 hours post rhinovirus(24 hours)
- Nasal IFN-α at 3 hours post rhinovirus infection(3 hours)
- Nasal IFN-α at 24 hours post rhinovirus infection(24 hours)
- Nasal IFN-α at 6 hours post rhinovirus infection(6 hours)