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

NCT ID: NCT06201494

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-06-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Jana Tuková

MUDr, Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jana Tukova, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Charles University, Czech Republic First Faculty of Medicine, Prague

Locations

First faculty of Medicine, Charles university.

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jana Tukova

Role: CONTACT

tukovajana@seznam.cz

+420608116653

Facility Contacts

Ilona Trtikova, Mgr., PhD

Role: primary

ilona.trtikova@lf1.cuni.cz

+420224965613

Other Identifiers

CZ-VFN-PEDMET-ASTHMA-001

Identifier Type: -

Identifier Source: org_study_id