Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The time until ready for discharge
研究概览
简要总结
We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months - 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.
详细描述
Introduction
Extensive surveys have shown that 6-20 % of children have acute expiratory wheezing (1, 2). The lifetime prevalence of wheezing among 12-14-year-old children in the Western countries is 8-19 % (3, 4). The clinical illness is called bronchiolitis when occuring for the first time in infants younger than 12 months (5). When occuring later or recurring, beside bronchiolitis a diagnosis of wheezy bronchitis has been used (6). In older children wheezy bronchitis cannot be distinguished from virus-induced-asthma. In many countries the first expiratory wheezing attack at the age of > 3 years is diagnosed as asthma. To some extent, bronchiolitis, wheezy bronchitis, and asthma are expressions of the same pathologic process and at present there are no rigid criteria to separate these three illnessess.
Acute bronchiolitis is most commonly caused by respiratory syncytial virus (RSV) and wheezy bronchitis by rhinovirus infections (6 - 8). Exacerbations of asthma are induced in 80-85% of the cases by viral respiratory infections in children, mostly rhinovirus infections (7, 9).
It is well established that systemic glucocorticoids are the cornerstone in the management of acute asthma (10). However, systemic glucocorticoids do not appear to be effective in bronchiolitis in young children (11). Despite the lack of evidence for efficacy, glucocorticoids are used up to 60 % of patients with RSV bronchiolitis (12).
The unfavourable effects of glucocorticoids during viral infections have received increasing attention. For example, steroids have been found to increase the risk of acute otitis media during rhinovirus infections in children (13). In adults glucocorticoids have increased the titers of rhinovirus and the shedding of the virus from the pharynx (14, 15). It may be possible that glucocorticoids increase the severity of some viral respiratory tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 3 months to 16 years
- •hospitalization for expiratory wheezing
- •written informed consent from the parents
排除标准
- •Any chronic disease (other than allergy or asthma), e.g. heart disease, immune deficiency, or diabetes
- •varicella and exposure to varicella if not previously have had it
- •Systemic glucocorticoid 4 weeks prios to the study
- •Severe disease that needs treatment in the intensive care unit or oxygen saturation below 92% despite of additional oxygen and frequent salbutamol inhalations
结局指标
主要结局
The time until ready for discharge
次要结局
- Oxygen saturation during hospital stay
- Wheeze and cough during two weeks after discharge from the hospital
- Readmission to the out-patient clinic or hospital for recurrent wheezing during a two-month period after discharge
- Blood eosinophil counts at discharge and two weeks later