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NCT Number: NCT06201494

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Tukova

CONTACT

[email protected]

+420608116653

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 11, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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