The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A measurable change in lung functions in response to paracetamol exposure.
研究概览
简要总结
Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.
Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.
This trial aims to identify a possible effect of single dose paracetamol on lower airway function.
详细描述
Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.
Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.
The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).
In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.
The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 7-16 years
- •research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
- •control group: children who are not known to have asthma
排除标准
- •paracetamol sensitivity
- •children with any kind of chronic disease (except asthma)
- •children with non asthma related chronic lung disease
- •acute asthma attack
- •children on systemic steroids
研究组 & 干预措施
asthmatic subjects
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
干预措施: paracetamol (Drug)
Healthy children
Children with no asthma as control group.
干预措施: paracetamol (Drug)
结局指标
主要结局
A measurable change in lung functions in response to paracetamol exposure.
时间窗: 1 year
次要结局
未报告次要终点