NCT06077019招募中不适用
Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals
Morten Hostrup, PhD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Exercise capacity during a time trial
研究概览
简要总结
The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Experimental
Participants inhale vilanterol + fluticasone furoat
干预措施: Vilanterol and Fluticasone Furoate (Drug)
Indacaterol
Experimental
Participants inhale indacaterol + mometasone furoate
干预措施: Indacaterol and Mometasone Furoate (Drug)
Placebo
Placebo Comparator
Participants inhale placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Exercise capacity during a time trial
时间窗: Through study completion, an average of 8 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
次要结局
- Lung function(Through study completion, an average of 8 weeks)
研究者
Morten Hostrup, PhD
Associate Professor
University of Copenhagen
研究点 (1)
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