Clinical trial NCT06201494: Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents
Official title: Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Asthma in Children
Dyspnea
Cough
Pneumonia
Wheezing
Shortness of Breath
Chest Tightness
Lower Respiratory Tract and Lung Infections
Recurrent Respiratory Tract Infections
Mucus; Plug
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with suspected diagnosis of asthma without any further chronic disease associated with respiratory symptoms.

Brief summary: 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.

Detailed description: 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.

Primary outcomes:
measure: Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: First faculty of Medicine, Charles university.
Study officials:
affiliation: Charles University, Czech Republic First Faculty of Medicine, Prague
name: Jana Tukova, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: