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临床试验/NCT04103632
NCT04103632已完成不适用

Screening and Diagnosing Exercise-induced Bronchoconstriction in Recreational Young Athletes (12-18 y)

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2019年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
2
主要终点
Detection of exercise-induced bronchoconstriction (EIB)

研究概览

简要总结

The purpose of this study is to validate the screening protocol to study risk factors of exercise-induced bronchoconstriction (EIB) obtained in our previous study in high-school elite athletes (NCT03587675), in recreational young athletes who perform intense physical exercise.

详细描述

Background: Physical exercise, though absolutely beneficial for human well-being, is a well-known trigger to induce bronchoconstriction. Exercise can provoke bronchoconstriction in subjects with pre-existing asthma but can also induce bronchoconstriction in otherwise healthy subjects. The latter phenomenon is called exercise-induced bronchoconstriction (EIB). EIB is frequent in the general population and might affect between 5 and 10% of them, although population based reports are scarce. EIB is most prevalent in individuals performing endurance sport disciplines, such as long distance running, duathlon and triathlon, cycling and cross-country skiing. Due to frequent intense physical training, its incidence is higher in elite athletes compared to non-elite athletes. Its prevalence in elite athletes within these endurance sport disciplines is estimated to be up to 13%. The percentage in aquatic endurance sports was surprisingly even higher and reached 20% in the Olympic games of 2008. Besides intense physical training, environmental factors such as chlorine or cold air exposure are therefore also linked to the appearance of EIB.

It remains very difficult to screen all athletes yearly for EIB. Therefore, the goal of this study is to define risk factors and/or biomarkers that might predict EIB, already at the start of their sport career. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of EIB.

The investigators already found that atopic individuals in a young cohort of elite athletes (12-13y) had increased risk to test positive for EIB (Fisher exact test p=0.04). However, due to the high number of subjects with a positive EIB test but negative Atopy/AQUA questionnaire, the AQUA questionnaire by itself can't be used to predict EIB (p=0.4). However, one out of five questions added by our group to this questionnaire ("Do the participant suffer from wheeze during exercise?") by itself predicted EIB with 93% specificity and 24% sensitivity. Adding a second question to this ("Has a doctor ever diagnosed the participant with an allergic condition?") increased the specificity to predict a positive EIB test to 99% but lowered sensitivity to 15% only (Jonckheere AC, J Allergy Clin Immunol, 2019). Based on the preliminary data of the slightly older cohort of also elite athletes (13-18 y), fractional exhaled nitric oxide (FeNO) levels (cut off 16 ppb) may be a useful indicator of atopic phenotypes among young elite athletes. Whether atopy is a risk factor for EIB in recreational young athletes who perform intense physical exercise has to be further studied.

Hypothesis: The investigators hypothesize that the findings in the cohort of elite athletes will be similar in the cohort of recreational athletes, performing at least 12 hours of sport a week. This means that:

  • They hypothesize that questionnaires (including AQUA questionnaire) can be used to screen for EIB
  • They hypothesize that atopy will be a risk factor for EIB
  • They hypothesize that increased FeNO levels will be a risk factor for EIB
  • They hypothesize that adding blood based biomarkers increase the predictive value of the screening protocol

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Recreational athletes who perform at least 12 hours of sports a week.

排除标准

  • Acute infection in four weeks prior the test.

结局指标

主要结局

Detection of exercise-induced bronchoconstriction (EIB)

时间窗: Baseline

Assessed by positive eucapnic voluntary hyperventilation (EVH test): at least 10% drop in FEV1% between 5-20' after EVH

次要结局

  • Use of blood biomarker to predict positive EVH test(Baseline)
  • Measurement of lung function by standard spirometry: FEV1 (L) and FVC (L)(Baseline)
  • Use of atopy to predict positive EVH test(Baseline)
  • Use of fractional exhaled nitric oxide (FeNO) levels to predict positive EVH test(Baseline)
  • Use of questionnaire to predict positive EVH test(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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