Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.
Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
研究概览
详细说明
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Keçiören
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Ankara、Keçiören、火鸡、06290
- Kecioren Education and Training Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 6 months to 6 years of age
- With at least three episodes of wheezing in the previous 12 months
- Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13
Exclusion Criteria:
- Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
- Who had any change in their dose of ICSs in the past 2 months
- Who had taken systemic corticosteroid within 1 months
- Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：1-Montelukast
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
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Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
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安慰剂比较：2- Placebo
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
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Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Difference of pulmonary index score from baseline to 120 minutes.
大体时间：0 to 120 minutes
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İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.
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0 to 120 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of discharge from emergency department.
大体时间：120, 180 and 240. minutes
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Proportion of subjects who were discharged from emergency department at 120,180 and 240.
minutes were compared between the montelukast and placebo groups.
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120, 180 and 240. minutes
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合作者和调查者
调查人员
- 研究主任：CEM H RAZİ, M.D.、Kecioren Education and Training Hospital
- 首席研究员：ELİF YAĞLI ÇOLAKOĞLU, M.D.、Kecioren Education and Training Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
montelukast 4 mg granule的临床试验
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