A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
2021年6月29日 更新者：Xijing Hospital
This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist（LTRA).
研究概览
详细说明
Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months.
Leukotriene receptor antagonist（LTRA).
For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast).
We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast.
Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy.
Additional goals include assessing risk factors for step-down failure.
研究类型
介入性
注册 (预期的)
90
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanxi
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Xi'an、Shanxi、中国、710032
- Department of Pediatrics, Xijing Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 14年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age 4-14 years
- patients had mild to moderate persistent asthma. Patients have treated with low-dose inhaled corticosteroids (equivalent to Fluticasone propionate inhaled aerosol 250 ug/ day) combined with Leukotriene receptor antagonist (Montelulast) at least 6 months of and had no symptoms of asthma for nearly 3 months under well asthma control(Asthma Control Test (ACT) score more than or equal to 20).
- patients did not suffer from other acute or chronic diseases that may affect their growth and development
Exclusion Criteria:
- patients with severe persistent asthma or mild persistent asthma failed to be well controlled by low-dose ICS after starting treatment
- suffer from other diseases: Congenital heart disease, chronic infectious disease, protracted diarrhea, congenital airway disease, congenital vascular ring malformation, congenital immune deficiency, tracheal foreign body, bronchial lymph node tuberculosis and gastroesophageal reflux etc.
- patients with poor compliance stop medication or fail to take medication on time.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Stop Fluticasone propionate Inhaled Aerosol Firstly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day
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The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
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有源比较器：Stop Montelukast Secondly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
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有源比较器：Stop Montelukast Firstly
stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
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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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Asthma Control Test (ACT) score
大体时间：Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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Change in participant's Asthma Control Test (ACT) score
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Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
大体时间：Baseline (Week 0) to Week 12
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Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
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Baseline (Week 0) to Week 12
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Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
大体时间：Baseline (Week 0) to Week 24
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Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
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Baseline (Week 0) to Week 24
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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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Fractional exhaled Nitric Oxide, FeNO
大体时间：Baseline, 12 weeks and 24 weeks
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Change in participant's Fractional exhaled Nitric Oxide
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Baseline, 12 weeks and 24 weeks
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Forced expiratory volume in one second in predicted（FEV1%pred）
大体时间：Baseline, 12 weeks and 24 weeks
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Change in participant's Forced expiratory volume in one second in predicted
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Baseline, 12 weeks and 24 weeks
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Forced vital capacity in predicted(FVC%pred)
大体时间：Baseline, 12 weeks and 24 weeks
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Change in participant's Forced vital capacity in predicted
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Baseline, 12 weeks and 24 weeks
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Maximal mid expiratory flow in predicted(MMEF%pred)
大体时间：Baseline, 12 weeks and 24 weeks
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Change in participant's Maximal mid expiratory flow in predicted
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Baseline, 12 weeks and 24 weeks
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Peak expiratory flow (PEF)
大体时间：Baseline, 12 weeks and 24 weeks
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Change in participant's Peak expiratory flow
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Baseline, 12 weeks and 24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年8月1日
初级完成 (预期的)
2022年8月1日
研究完成 (预期的)
2022年8月1日
研究注册日期
首次提交
2021年6月11日
首先提交符合 QC 标准的
2021年6月29日
首次发布 (实际的)
2021年7月8日
研究记录更新
最后更新发布 (实际的)
2021年7月8日
上次提交的符合 QC 标准的更新
2021年6月29日
最后验证
2020年9月1日
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.