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临床试验/NCT04184609
NCT04184609撤回4 期

Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes

Ohio State University1 个研究点 分布在 1 个国家开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Peripheral airway reactivity (R5-R20)

研究概览

简要总结

The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children.

详细描述

Obesity and asthma are the most common diseases of childhood, causing activity limitation and impaired quality of life. Most obese asthmatic children report dyspnea on exertion (DOE) as their primary asthma symptom. Fear of dyspnea promotes sedentariness and reduces exercise capacity and quality of life. DOE in asthmatic children is typically attributed to bronchoconstriction but it is also possible that obesity is an equal or even major contributor to dyspnea. Excess chest and abdominal weight in obese children results in low lung volumes, which increases the risk of mechanical ventilatory constraints such as expiratory flow limitation, dynamic hyperinflation, and airway closure, all of which can provoke DOE. Unnecessary use of corticosteroids and other asthmatic medication in obese asthmatic children cannot treat obesity-specific mechanical ventilatory constraints and could have unintended deleterious effects. Therefore, there is an urgent need to better understand the mechanisms involved in DOE to provide evidence-based symptom management for obese asthmatic children that will promote regular physical activity and lessen DOE.

The overall objective of this study is to better understand the respiratory mechanisms provoking DOE in obese asthmatic children. The investigators hypothesize that low lung volume breathing in obesity leads to mechanical ventilatory constraints in the presence or absence of bronchoconstriction during exercise. Whereas DOE attributable to bronchoconstriction should respond to bronchodilators, DOE attributable to obesity-specific mechanical ventilatory constraints will not respond to bronchodilators. A comprehensive physiological pulmonary function and exercise-testing based approach will be used to identify 9-17-year-old obese asthmatic children who do and do not bronchoconstrict during exercise. The presence/absence of bronchoconstriction will be determined by a comprehensive measure of exercise-induced central and peripheral airway reactivity using spirometry and impulse oscillometry (i.e., greater than or equal to 10% reduction in forced expiratory volume in 1s, FEV1, or greater than or equal to 40% increase in peripheral airway resistance, R5-20, will be indicative of bronchoconstriction). The investigators will also determine the mechanisms by which bronchodilators like albuterol affect bronchoconstriction amd mechanical ventilatory constraints in asthmatic children with obesity.

研究设计

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

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Exercise test

Experimental

All participants will undergo a moderate-intensity exercise test under three conditions in a repeated measures study design:

  1. Control
  2. Albuterol

干预措施: Control (Other)

Exercise test

Experimental

All participants will undergo a moderate-intensity exercise test under three conditions in a repeated measures study design:

  1. Control
  2. Albuterol

干预措施: Albuterol (Drug)

结局指标

主要结局

Peripheral airway reactivity (R5-R20)

时间窗: Pre to 30 min post exercise

Units: % change from pre to post exercise, measured with impulse oscillometry

Expiratory flow limitation

时间窗: up to 2 hours during the intervention (exercise)

Units: % of tidal volume, measured as overlap between exercise tidal flow volume loop and maximal expiratory flow volume loop

Dynamic hyperinflation

时间窗: up to 2 hours during the intervention (exercise)

Units: % of total lung capacity, measured as change in end-expiratory lung volume from rest to exercise

Forced expiratory volume in 1 s

时间窗: Pre to 30 min post exercise

Units: Litres, measured with spirometry

次要结局

  • Rating of perceived breathlessness(up to 2 hours during the intervention (exercise))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dharini Bhammar

Assistant Professor

Ohio State University

研究点 (1)

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