A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 主要终点
- Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
研究概览
简要总结
This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.
详细描述
The duration of treatment is a one time dose.
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, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks
排除标准
- •Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
研究组 & 干预措施
2
montelukast sodium
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
时间窗: Baseline and (time weighted average over) 60 Minutes
Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
次要结局
- Change in FEV1 After 15 Minutes Following the End of Study Drug Administration(Baseline and 15 Minutes)
- Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration(Baseline and (time-weighted average over) 30 Minutes)
- Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration(120 minutes)
- Change From Baseline in Modified Pulmonary Index [mPI] Score(Baseline and 60 minutes)
- Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration(Baseline and (time-weighed average over) 45 Minutes)
- Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)(120 minutes)