A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
研究概览
简要总结
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 patients 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
- •Physician-diagnosed exercise-induced bronchospasm
排除标准
- •Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
研究组 & 干预措施
4
Salmeterol - Placebo - Montelukast
干预措施: Comparator: Salmeterol (Drug)
3
Salmeterol - Montelukast - Placebo
干预措施: Comparator: Placebo (montelukast) (Drug)
6
Placebo - Salmeterol - Montelukast
干预措施: Comparator: Placebo (montelukast) (Drug)
6
Placebo - Salmeterol - Montelukast
干预措施: Comparator: Placebo (salmeterol) (Drug)
1
Montelukast - Salmeterol - Placebo
干预措施: Comparator: Placebo (montelukast) (Drug)
1
Montelukast - Salmeterol - Placebo
干预措施: Comparator: Placebo (salmeterol) (Drug)
3
Salmeterol - Montelukast - Placebo
干预措施: Comparator: Placebo (salmeterol) (Drug)
2
Montelukast - Placebo - Salmeterol
干预措施: Comparator: Placebo (montelukast) (Drug)
2
Montelukast - Placebo - Salmeterol
干预措施: Comparator: Placebo (salmeterol) (Drug)
4
Salmeterol - Placebo - Montelukast
干预措施: Comparator: Placebo (montelukast) (Drug)
4
Salmeterol - Placebo - Montelukast
干预措施: Comparator: Placebo (salmeterol) (Drug)
5
Placebo - Montelukast - Salmeterol
干预措施: Comparator: Placebo (montelukast) (Drug)
5
Placebo - Montelukast - Salmeterol
干预措施: Comparator: Placebo (salmeterol) (Drug)
5
Placebo - Montelukast - Salmeterol
干预措施: Comparator: Montelukast (Drug)
5
Placebo - Montelukast - Salmeterol
干预措施: Comparator: Salmeterol (Drug)
4
Salmeterol - Placebo - Montelukast
干预措施: Comparator: Montelukast (Drug)
3
Salmeterol - Montelukast - Placebo
干预措施: Comparator: Salmeterol (Drug)
3
Salmeterol - Montelukast - Placebo
干预措施: Comparator: Montelukast (Drug)
2
Montelukast - Placebo - Salmeterol
干预措施: Comparator: Salmeterol (Drug)
2
Montelukast - Placebo - Salmeterol
干预措施: Comparator: Montelukast (Drug)
1
Montelukast - Salmeterol - Placebo
干预措施: Comparator: Salmeterol (Drug)
1
Montelukast - Salmeterol - Placebo
干预措施: Comparator: Montelukast (Drug)
6
Placebo - Salmeterol - Montelukast
干预措施: Comparator: Salmeterol (Drug)
6
Placebo - Salmeterol - Montelukast
干预措施: Comparator: Montelukast (Drug)
结局指标
主要结局
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
时间窗: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
In patients 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 Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose(0-90 minutes after the exercise challenge performed at 2 hours postdose)
- Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose(0-90 minutes after the exercise challenge performed at 8.5 hours postdose)
- Number of Patients Requiring β-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 8.5 Hours Post-dose in Patients With EIB(0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB(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 0-60 Min) at 2 Hours Postdose(0-60 minutes after the exercise challenge at 2 hours postdose)
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose(0-60 minutes after the exercise challenge at 8.5 hours postdose)
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose(0-60 minutes after the exercise challenge 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)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose(Exercise challenge at 8.5 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose(Exercise challenge at 24 hours postdose)