Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- changes of lung function after interventions
研究概览
简要总结
As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •known cases of controlled bronchial asthma
- •≧4 years of age
- •the result was positive after acetylcholine provocation test in follow-up visit
排除标准
- •had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day
- •had fever (axillary temperature>38.5℃)
- •history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
- •history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium
研究组 & 干预措施
nebulized magnesium sulfate
nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once
干预措施: Magnesium Sulfate (Drug)
nebulized magnesium sulfate & albuterol
nebulized magnesium sulfate 150mg & albuterol 2.5mg and consisted about 5 min,which used only once
干预措施: magnesium sulfate & albuterol (Drug)
nebulized albuterol
nebulized albuterol 2.5mg and consisted about 5 min,which used only once
干预措施: Albuterol (Drug)
结局指标
主要结局
changes of lung function after interventions
时间窗: 10 min and 20 min post-dose
to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate, albuterol, or combination of magnesium sulfate and albuterol respectively.
次要结局
- effectiveness of nebulized magnesium sulfate alone(10 min and 20 min post-dose)
- the number of patients with adverse events as a measure of safety and tolerability(20 min)
研究者
Dai Jihong
professor
Chongqing Medical University