Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Power output during sprint testing
研究概览
简要总结
The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-39
- •Physically active > 5 h weekly
- •Maximal oxygen consumption classified as high or very high
排除标准
- •Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- •ECG abnormality
- •ACQ score > 1.5
- •Severe bronchial hyperreactivity as determined by mannitol test
- •FEV1/FVC ratio < 0.7 determined with spirometry
- •Chronic illness determined to be a potential risk for participant during study
- •In chronic treatment with medication that may interfere with study results
- •Pregnancy
- •Blood donation during the past 3 months
研究组 & 干预措施
Vilanterol + fluticasone furoate
Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing
干预措施: Vilanterol and Fluticasone Furoate (low dose) (Drug)
Vilanterol + fluticasone furoate
Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing
干预措施: Vilanterol and Fluticasone Furoate (high dose) (Drug)
Placebo
Participants are administered placebo from an inhaler device testing
干预措施: Placebo (Drug)
结局指标
主要结局
Power output during sprint testing
时间窗: Through study completion, an average of 3 weeks
Power output measured in Watts during a sprint on a bike ergometer
次要结局
- Power output during time trial(Through study completion, an average of 3 weeks)
研究者
Morten Hostrup, PhD
Associate Professor
University of Copenhagen