The Prevalence of Exercise-Induced Laryngeal Obstruction (EILO) Amongst Children With Asthma' - a Prospective Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Prevalence of EILO
研究概览
简要总结
The goal of this cross-sectional study is to investigate the prevalence of Exercise Induced Laryngeal Obstruction (EILO) in children with asthma.
The hypothesis is that the prevalence will be around 15%, which is higher than the prevalence of 5-8% among the general adolescent population. This is based on the increased prevalence of EILO among adult asthmatics.
Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves, and fill in the Borg scale for dyspnea, Asthma Control Test, EILODI questionnaire and DISCO-RC questionnaire.
详细描述
Background:Exertional dyspnoea is a common and limiting symptom within the paediatric population. Regular physical activity is paramount for the development of children since it not only promotes cardiorespiratory fitness and muscle strength, but also offers opportunities for self-expression, building confidence and social interaction and integration. It is therefore important to identify the correct cause(s) of exertional dyspnea and reverse them to enable children to be active without symptoms.
Exercise induced bronchoconstriction (EIB) is a well-known cause of exertional dyspnoea and is highly specific of childhood asthma. Another less recognized cause of exertional dyspnoea is exercise induced laryngeal obstruction (EILO). EILO is an inappropriate closure of the larynx during strenuous physical activity with no obvious laryngeal pathology at rest, limiting airflow and causing inspiratory stridor. It can co-exist with and mimic symptoms of EIB.
Previous studies showed a prevalence of 6% in adolescent populations). However, recent studies revealed a much higher prevalence ofEILO in adults with asthma, up to 25-47%. The prevalence of EILO amongst children with asthma has not yet been investigated. In this study, the aim is to investigate the prevalence of EILO in children with asthma.
If EILO is a significant comorbidity of childhood asthma this would implicate that EILO screening should be considered when exercise is a persistent trigger of symptoms in asthmatic children. Correct EILO diagnosis and treatment can lead to adequate treatment of EILO, and to prevention of overtreatment of asthma.
Methods: Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves, and fill in the Borg scale for dyspnea, Asthma Control Test, EILODI questionnaire and DISCO-RC questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 18 years
- •Paediatrician diagnosed asthma confirmed with at least one of the following during the last two years: Positive ECT (post-exercise fall in FEV1 > 10%) / Positive methacholine test (PC20 value of ≤8 mg/mL) / Bronchodilator reversibility (increase in FEV1 ≥12% and/or ≥200 mL following inhalation of 200-400 μg short-acting β2-agonists)
排除标准
- •Other severe cardiopulmonary disease
- •Inability to perform ECT or CLE test
- •Inability to perform technically acceptable spirometry
- •Asthma exacerbation or respiratory tract infection in the last 2 weeks
- •Short-acting β2-agonists or long-acting β2-agonists use less than respectively 8 and 24 hours before the ECT or CLE test
- •Oral corticosteroid use in the 4 weeks before the ECT or CLE test
结局指标
主要结局
Prevalence of EILO
时间窗: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years
Prevalence of EILO (defined as Maat score grade 2 or higher) in study population, with 95% confidence interval
次要结局
- Prevalence of EILO with and without current EIB(During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of gender with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of length with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of weight with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of BMI Z score with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of type of sports with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of medication use with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of comorbidities with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of age with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of maximal exercise intensity (wattage/kg or maximum running pace and slope) with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of Asthma Control Test (ACT) with EILO(During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of hours of moderate-to-vigorous weekly activity with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of type of reported symptoms with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of heart rate during exercise with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of baseline FEV1 (% predicted) with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of maximal % post-exercise fall in FEV1 with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of athletic performance (none/local/regional/national/international) with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of recognizable symptoms with presence of EILO(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of Exercise-Induced Laryngeal Obstruction Dyspnea Index (EILODI) with EILO(During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of Visual Analogue Scale (VAS) with EILO(During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Association of combination of questionnaire scores (Asthma Control Test (ACT), Exercise-Induced Laryngeal Obstruction Dyspnea Index (EILODI) and/or Visual Analogue Scale (VAS)) with EILO(During CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Comparison of test duration between participants with similar and non-similar EIB results during CLE and ECT test(During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Comparison of heart rate between participants with similar and non-similar EIB results during CLE and ECT test(During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Inter-rater agreement of EILO diagnosis between two participating hospitals(During CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Assesment of EIB with CLE compared to ECT test(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Comparison of age between participants with similar and non-similar EIB results during CLE and ECT test(During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)
- Self-reported discomfort of CLE test(After the CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years)