NCT00092131已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
研究概览
简要总结
The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who have a history of worsening asthma after exercise.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with mild-to-moderate asthma
排除标准
- •Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
结局指标
主要结局
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
时间窗: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
次要结局
- Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose(0-90 minutes after the exercise challenge performed at 12 hours postdose)
- Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose(0-90 minutes after the exercise challenge performed at 2 hours postdose)
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose(Exercise challenge at 2 hours postdose)
- Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose(0-90 minutes after the exercise challenge performed at 24 hours postdose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose)
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose)
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose(Exercise challenge at 12 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose(Exercise challenge at 24 hours postdose)
研究者
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