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临床试验/NCT07766460
NCT07766460已完成不适用

Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月30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
100
试验地点
1
主要终点
Presence of wheezing at exercise

研究概览

简要总结

Exertional dyspnea has a significant impact on a child's daily life. Current guidelines recommend performing an exercise challenge test to confirm or rule out exercise-induced bronchoconstriction (EIB). But the test is not widely available. The objective of this research is to identify the clinical and respiratory functional factors predictive of a positive exercise challenge test in children.

详细描述

Exertional dyspnea is a frequent reason for consultation in pediatric pulmonology. The perception of dyspnea varies from one child to another, with some children over- or under- perceiving its intensity. Dyspnea has a significant impact on a child's daily life and quality of life and, in pediatrics, always raises the suspicion of exercise-induced asthma. Current guidelines recommend performing an exercise challenge test to confirm or rule out exercise-induced bronchoconstriction (EIB) if it is suspected. However, this test is not widely available. The objective of this research is to identify the clinical and respiratory functional factors predictive of a positive exercise challenge test in children.

The potential benefit of this study is to better identify individuals who would benefit from undergoing an exercise challenge test.

研究设计

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

入排标准

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

入选标准

  • •Children aged 5 to 18 years who performed an exercise challenge test during the years 2024 and 2025

排除标准

  • •Children with doctor-diagnosed asthma

研究组 & 干预措施

Children with exercise-induced bronchocontriction

Children with a reduction in FEV1 ≥ 10% from baseline after the exercise challenge test

Children without exercise-induced bronchocontriction

Children with a reduction in FEV1 < 10% from baseline after the exercise challenge test

结局指标

主要结局

Presence of wheezing at exercise

时间窗: The test duration (3 hours)

Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).

次要结局

  • Presence of reported dyspnea at exercise(The test duration 3 hours)
  • Presence of reported cough at exercise(The test duration 3 hours)
  • Presence of reported chest tightness at exercise(The test duration 3 hours)
  • Functional parameters - FEV1 z-score at baseline(The test duration 3 hours)
  • Reported atopy(The test duration 3 hours)
  • Reported clinical history(The test duration 3 hours)
  • Functional parameters - FEV1/FVC z-score at baseline(The test duration 3 hours)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Iulia IOAN

Associate Professor MD PhD

Central Hospital, Nancy, France

研究点 (1)

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