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Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents
NCT06201494 · Charles University, Czech Republic
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
Eligibility criteria
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.
Study design
Enrollment target: 80 participants
Age groups: child, adult
Timeline
Starts: 2023-01-01
Estimated completion: 2027-06-01
Last updated: 2026-07-14
Primary outcomes
- • Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale (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.)
Sponsor
Charles University, Czech Republic · other
Contacts & investigators
ContactJana Tukova · contact · tukovajana@seznam.cz · +420608116653
InvestigatorJana Tukova, MD,PhD · principal_investigator, Charles University, Czech Republic First Faculty of Medicine, Prague
All locations (1)
First faculty of Medicine, Charles university.Recruiting
Prague, Czechia