Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
研究概览
简要总结
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
详细描述
This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.
Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 12-17 years of age
- •Physician diagnosed asthma for at least 6 months
- •Long term controller medication for at least 4 weeks if any being used
- •Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
- •EIB diagnosed by a positive exercise challenge at screening
- •Forced expiratory volume in 1 second (FEV1) greater than 70% of predicted at screening visit
排除标准
- •History of cardiac dysfunction
- •Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
- •Upper respiratory infection in the last 4 weeks
- •Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
- •Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
- •Pregnancy or lactation
- •History of paradoxical bronchospasm with any beta-agonist
- •Obesity defined as BMI greater than 30 kg/m2
研究组 & 干预措施
2
1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer
干预措施: formoterol (Drug)
3
1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer
干预措施: placebo (Drug)
1
15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder
干预措施: arformoterol (Drug)
结局指标
主要结局
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
时间窗: April 2008-April 2010
次要结局
- Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.(April 2008- April 2010)
研究者
Hengameh Raissy, Pharm.D.
Research Associate Professor, Pediatrics
University of New Mexico