Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
研究概览
简要总结
Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
HYPOTHESIS:
Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.
详细描述
Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. There are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. All the studies showed significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. However, these studies are carried out in adults. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.
排除标准
- •Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
- •Children who had received montelukast within one week of arrival.
- •Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
- •Children with altered sensorium/unable to take oral medication.
研究组 & 干预措施
A1
Children Between 5-15 Years of Age Receiving Montelukast
干预措施: montelukast (Drug)
A2
Children Between 5-15 Years of Age Receiving Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
时间窗: 4 hours
次要结局
- Change in FEV1 at the end of 4 hours(4 hours)
- Adverse effects: Headache, nausea, vomiting, abdominal pain(4 hours)
- Need for hospitalization(4 hours)