Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
2022年2月4日 更新者：Organon and Co
A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
154
阶段
- 第三阶段
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
6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:
- 6-14 year old children with a history of asthma for at least 12 months
- must demonstrate airway constriction brought on by exercise
Exclusion Criteria:
- is taking any medications that are not allowed in the study
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：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Montelukast/Salmeterol
Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo).
Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Montelukast 5 mg chewable tablet once daily
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Matching placebo to montelukast oral tablet administered once daily.
Matching placebo to salmeterol dry powder for inhalation administered twice daily
|
|
实验性的：Salmeterol/Montelukast
Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo).
Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Montelukast 5 mg chewable tablet once daily
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Matching placebo to montelukast oral tablet administered once daily.
Matching placebo to salmeterol dry powder for inhalation administered twice daily
|
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 |
|---|---|---|
|
Maximum Post-exercise Percent (%) Fall in FEV1
大体时间：4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
|
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
大体时间：4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.
|
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
|
Maximum FEV1 % Predicted Following First Beta-agonist Use
大体时间：4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.
|
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
|
Time to Recovery to Within 5% of Baseline FEV1
大体时间：4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.
|
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
|
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
大体时间：4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.
|
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
|
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
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2005年12月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2005年6月30日
首先提交符合 QC 标准的
2005年8月4日
首次发布 (估计)
2005年8月5日
研究记录更新
最后更新发布 (实际的)
2022年2月11日
上次提交的符合 QC 标准的更新
2022年2月4日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 0476-911
- 2004_006 (其他标识符：Merck Registration Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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.
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