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临床试验/NCT03696602
NCT03696602已完成不适用

More Relaxation by Deep Breath on Methacholine- Than on Exercise-Induced Bronchoconstriction During the Routine Testing of Asthmatic Children

Central Hospital, Nancy, France0 个研究点目标入组 78 人开始时间: 2006年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
主要终点
Grs change between before deep breath and after deep breath in exercise and metacholine groups

研究概览

简要总结

Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. The hypothesis tested was that DI induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.

详细描述

Children were referred to the lung function department by their pediatric pulmonologist. Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge.

The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1) decreased at least 8% from Baseline.

The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.

Bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed consent was obtained from the children and their parents for the procedures. Procedures for spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi square tests and multiple regression as required. Data are median and interquartile range.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children referred to the lung function department by their pediatric pulmonologist.
  • Asthma defined by a complaint of wheezing, cough and dyspnoea.
  • Positive response to methacholine or exercise challenge.
  • Bronchodilator medications discontinued at least 12 h prior to the testing
  • Provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 larger than 70% pred.

排除标准

  • Other respiratory diseases than asthma

结局指标

主要结局

Grs change between before deep breath and after deep breath in exercise and metacholine groups

时间窗: through study completion, an average of 1 hour

GrsDI represents Grs measured after deep breath reported to Grs before deep breath (bronchial provocation test)

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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