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临床试验/NCT06201494
NCT06201494招募中不适用

Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale

研究概览

简要总结

Bronchial asthma may present with symptoms other than the commonly reported complaints (cough, chest tightness, shortness of breath and wheezing). Less common symptoms include chronic or recurrent productive cough, inspiratory dyspnoea or recurrent pneumonia. Children presenting with these symptoms are often diagnosed with asthma bronchiale and benefit from antiasthmatic management.

详细描述

International guidelines for the diagnosis of bronchial asthma list cough, chest tightness, shortness of breath and wheezing as the four basic symptoms of asthma. The diagnosis of bronchial asthma is based on the presence of two or more of these symptoms over time, together with evidence of bronchial hyperresponsiveness and a favourable response to antiasthmatic treatment. In children under 5 years of age, the occurrence of an isolated cough as a possible asthma symptom (cough variant asthma) is also accepted if bronchial hyperresponsiveness is documented and the difficulty subsides on therapy. Pulmonologists also refer children over 5 years of age who have only an isolated cough with no other symptoms before diagnosis.

In practice, however, it is also possible to see children whose asthma initially manifests as conditions assessed as recurrent pneumonia, isolated chronic cough of a moist nature or as inspiratory dyspnoea. These atypical symptoms are not oficially counted as asthma symptoms. In this study, the investigators focus on prevalence of typical and atypical asthma symtpoms. Furthermore, the investigators study sensitivity of offical asthma symptom questinaire ISAAC in children with typical and atypical asthma symptoms.

研究设计

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

入排标准

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

入选标准

  • - Child 3 - 18 years old, first evaluation in pulmonary outpatient clinic for any of the following respiratory symptoms: cough, shortness of breath, chest tightness, wheezing, recurrent lower respiratory tract and lung infections, dyspnoea of any type, pathological listening findings.

排除标准

  • Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.

结局指标

主要结局

Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale

时间窗: Initial checkup with asthma symptom documentation and answering the ISAAC questionaire. Suspection on asthma diagnosis and initiation of therapy and scheduled follow-up within 3 months to confirm the diagnosis.

We study prevalence of asthma symptoms in children with newly diagnosed asthma. We monitor atypical and atypical symptoms. Typical symptoms are cough, chest tightness, shortness of breath and wheezing according to current global asthma guidelines (GINA). Atypical symptoms are not yet fully documented in literature but they might be represented by recurrent pneumonia, isolated chronic wet cough or inspiratory dyspnoea. Comparison of sensitivity of ISAAC questionaire in group of children with typical and atypical asthma symptoms. In practice, however, it is also possible to see children whose asthma initially manifests as conditions assessed as recurrent pneumonia, isolated chronic cough of a moist nature or as inspiratory dyspnoea. These atypical symptoms are not oficially counted as asthma symptoms. In our study, we focus on prevalence of typical and atypical asthma symtpoms. We study sensitivity of questionaire ISAAC in children with typical and atypical asthma symptoms.

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jana Tuková

MUDr, Phd

Charles University, Czech Republic

研究点 (2)

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