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临床试验/NCT00731575
NCT00731575Unknown不适用

Viral Inception of Asthma: Prospective Study From Infancy to School-age.

University of Turku1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Diagnosis of asthma

研究概览

简要总结

The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e., recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events.

Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the "common cold" virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus infections is associated with atopy and therefore it is possible these children may have impaired anti-inflammatory (Treg) responses and more likely to wheeze with any pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses, because they can not limit rhinovirus to nose and it spreads to lower airways and causes wheezing. VINKU 2-study will prospectively investigate the immunological events in young first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of systemic corticosteroid in them. Most likely these children will benefit from the drug in terms of less recurrent wheezing, the investigators will also explore immunological effects of the drug and their link to clinical efficacy. The results are expected to give basis for the prevention of asthma and for the development of new treatment strategies and they can be directly applied to clinical medicine.

详细描述

Main Hypothesis and Anticipated Results

Virology

  1. Rhinovirus is a common causative agent of bronchiolitis.
  2. Persistence of rhinovirus (or any virus) infection worsens long-term outcome.
  3. The dose of virus inoculation at the time of acute wheezing (assessed semi-quantitatively for rhinovirus and respiratory syncytial virus) is related to outcome.

Immunology 4. Children susceptible to rhinovirus induced early wheezing have altered immunology (T cell regulation and interferon responses) when compared to children with RSV induced wheezing and children with rhinovirus induced upper respiratory infection without wheezing. 5. These immunological events are related to recurrent wheezing and asthma inception.

Therapeutic intervention with systemic corticosteroid

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • age 3-23 months
  • be delivered at >=37 weeks
  • first wheezing episode
  • written informed consent from guardian

排除标准

  • chronic illness other than atopy
  • previous systemic or inhaled corticosteroid treatment
  • participation to another study
  • varicella contact if previously intact
  • need for intensive care unit treatment, or
  • poor understanding of Finnish

结局指标

主要结局

Diagnosis of asthma

时间窗: 1-7 years

次要结局

  • Home diary recordings for airway symptoms(12 months)

研究者

申办方类型
Other

研究点 (1)

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