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临床试验/NCT00375232
NCT00375232撤回不适用

Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Indiana University School of Medicine2 个研究点 分布在 1 个国家开始时间: 2006年10月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Improvement in indices of ventilation and cardiopulmonary response measured on CPST

研究概览

简要总结

The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.

详细描述

Exercise-Induced Bronchospasm (EIB) affects between 7-30% of highly trained athletes. The first phase of this study is to screen varsity level college athletes for EIB using Eucapnic hyperventilation (EVH). Those athletes who screen positive, will be enrolled in phase two, a randomized double-blinded placebo controlled double crossover study. At enrollment, athletes will undergo a cardiopulmonary stress test (CPST) and induced sputum sampling and will then be prescribed daily montelukast/placebo for a three week period. Athletes will return after three weeks and repeat the EVH, CPST, and induced sputum. They will then have a one week washout period followed by crossover once again to daily montelukast/placebo for another three weeks. After the second three weeks they will once again return for a final EVH, CPST, and induced sputum. The goal of this study is to demonstrate that effectively blunting the EIB response with montelukast, indices of ventilation,exercise tolerance, and perhaps overall physical fitness improve, allowing athletes to train more effectively, in a nonergogenic manner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • College level varsity athlete
  • age 18yr or older
  • Able to swallow pills
  • No prior history of asthma

排除标准

  • Younger than 18yr
  • Prior history of asthma
  • Unable to swallow pills

结局指标

主要结局

Improvement in indices of ventilation and cardiopulmonary response measured on CPST

Effective blunting of the EIB response by Spirometric measurement

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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