NCT04168671撤回不适用
Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Laryngeal obstruction
研究概览
简要总结
The purpose is to assess visualize the level of laryngeal obstruction and vocal cord dysfunction and to obtain more information on causes for dyspnea in asthma and severe asthma and to assess safety of CLE in patients with asthma and with severe asthma. Patients are examined if symptomatic during exercise.
详细描述
- Questionnaires to assess breathlessness before the test.
- CLE on ergometer bicycle using any laryngoscopy setup
- Ergometry with spirometry tests with ECG, oxygen saturation, blood pressure, inspiratory and expiratory flow volume curves, bronchodilator after the exercise test
- Work load of 40W with 3 minutes intervals and increase by 40W in women. In men, work load of 50W with 3 minutes intervals and increase by 50W starting from 50W. In elderly and more severely disease work load of 30W with 3 minutes intervals and increase by 30W.
- Recording of dyspnoea, leg fatigue and chest discomfort
- Assessment of asthma by asthma control test, spirometry, exhaled NO measurements.
- Severe asthma group: physician-diagnosed asthma, moderate-high dose inhaled glucorticoid steroids and a second controller drug, exacerbations and per oral glucocorticoid steroid courses at least 2 in the past 12 months and/or 50% of the past 12 months on per oral glucocorticoidsteroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician diagnosed asthma
- •symptomatic during exercise
排除标准
- •FEV1 <60%
- •respiratory infection in the last 14 days
- •asthma excacerbation in the last 14 days
- •unstable cardiovascular disease
- •bleeding disorder
- •anticoagulant treatment (other than ASA)
研究组 & 干预措施
Asthma
Other
Asthma and symptomatic during exercise
干预措施: Continuous laryngoscopy during exercise test (Diagnostic Test)
Severe asthma
Other
Severe asthma and symptomatic during exercise
干预措施: Continuous laryngoscopy during exercise test (Diagnostic Test)
结局指标
主要结局
Laryngeal obstruction
时间窗: From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes
Semi-quantitative visual estimation of laryngeal obstruction in test
次要结局
- Safety of CLE in asthma (Incidence of test-emergent adverse events)(From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes)
- Exercise capacity in CLE in asthma(From 0 minutes before the exercise test and during the test up to 30 minutes)
- Dyspnea in CLE in asthma(From 0 minutes before the exercise test and during the test up to 30 minutes)
- Exercise induced lung function changes(Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test)
研究者
Paula Kauppi, MD, PhD
MD, PhD, Chief Specialist
Helsinki University Central Hospital
研究点 (1)
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