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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Cough; Asthma; Asthma in Children; Dyspnea; Recurrent Respiratory Tract Infections; Shortness of Breath; Wheezing; Mucus; Plug; Lower Respiratory Tract and Lung Infections; Chest Tightness

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jana Tukova; Phone Number: +420608116653; Email: tukovajana@seznam.cz

Study Locations

• Czechia
  • Prague, Czechia, 128 00
    • Recruiting
    • First faculty of Medicine, Charles university.
    • Contact: Ilona Trtikova, Mgr., PhD; Phone Number: +420224965613; Email: ilona.trtikova@lf1.cuni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Jana Tukova, MD,PhD, Charles University, Czech Republic First Faculty of Medicine, Prague

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Infections; Communicable Diseases; Asthma; Respiratory Tract Infections; Respiratory Sounds; Dyspnea
• Other Study ID Numbers: CZ-VFN-PEDMET-ASTHMA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
• IPD Sharing Time Frame: After completion of study and its publication. For 5 years.
• IPD Sharing Access Criteria: Proposals should be submitted to jana.tukova@vfn.cz.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No