Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Power output during time trial
研究概览
简要总结
The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45
- •Physically active >5 hours a week
- •Maximum oxygen uptake 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
- •FEV1/FVC ratio < 0,7 determined with spirometry
- •Chronic illness determined to be a potential risk for participant during the study
- •In chronic treatments with medication that may interfere with study results
- •Pregnancy
- •Blood donation during the past 3 months
研究组 & 干预措施
Symbicort - usual care
Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.
干预措施: Symbicort (Drug)
Formoterol - inhalation
Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.
干预措施: Formoterol (Drug)
Formoterol - oral
Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.
干预措施: Formoterol (Drug)
Placebo
Participants are administered placebo from an inhaler device testing and a placebo capsule.
干预措施: Placebo (Drug)
Mannitol-test
Participants are administered Bronchitol from an inhaler device testing.
干预措施: Mannitol (Drug)
结局指标
主要结局
Power output during time trial
时间窗: Through study completion, an average on 4 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
次要结局
- Power output during sprint testing(Through study completion, an average on 4 weeks)
研究者
Morten Hostrup, PhD
Associate Professor
University of Copenhagen