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

NCT06201494 | Recruiting

• 1 other identifier: CZ-VFN-PEDMET-ASTHMA-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with suspected diagnosis of asthma without any further chronic disease associated with respiratory symptoms.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

First faculty of Medicine, Charles university.

Prague, 128 00, Czechia

RECRUITING

MeSH Terms

Conditions

Asthma; Dyspnea; Cough; Pneumonia; Respiratory Sounds; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Jana Tukova, MD,PhD

  Charles University, Czech Republic First Faculty of Medicine, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Tukova

CONTACT

+420608116653; tukovajana@seznam.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr, Phd

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of study and its publication. For 5 years.
• Access Criteria: Proposals should be submitted to jana.tukova@vfn.cz.

Locations

CZ (1)