A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 364
- 主要终点
- Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
研究概览
简要总结
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is 4 years to 14 years of age
- •The child is a non smoker
- •The child has exercise-induced bronchoconstriction (EIB)
排除标准
- •The child has active or chronic breathing disease, other than asthma
- •The child has required insertion of a breathing tube for asthma
- •The child had major surgery within the last 4 weeks
- •The child is currently in the hospital
- •The child has or had an upper respiratory tract infection within the last 2 weeks
- •The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
- •The child has been in a research study in the last 4 weeks
- •The child has stomach, brain, heart, kidney or liver disease
- •The child drinks more that 4 caffeinated drinks a day
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 Postdose
时间窗: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose
Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, \& 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was \[100\*(1-(X/Y))\] where X= the lowest FEV1 within 60 mins after exercise \& Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.
次要结局
- Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose(Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose)
- Number of Participants Requiring Rescue Medication at 2 Hours Postdose(0-90 minutes after the exercise challenge at 2 hours postdose)
- Number of Participants Requiring Rescue Medication at 24 Hours Postdose(0-90 minutes after the exercise challenge at 24 hours postdose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose(Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose)
- Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose(Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose)
- Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose(0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose)
- Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose(0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose)