AsthmaNCT06201494
Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents
An observational study of Asthma and Asthma in Children, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Asthma, Asthma in Children, Dyspnea
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Child, Adult
Study population: Children with suspected diagnosis of asthma without any further chronic disease associated with respiratory symptoms.
Who may be able to join
- 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.
Who cannot join
- Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
First faculty of Medicine, Charles university.
Prague, 128 00
Ilona Trtikova, Mgr., PhD, +420224965613, ilona.trtikova@lf1.cuni.cz
About this study
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.
Read the 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.
- Medical subject headings
- Asthma, Dyspnea, Cough, Pneumonia, Respiratory Sounds, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana Tuková, Charles University, Czech Republic
- Investigators
- Jana Tukova, MD,PhD, Principal investigator, Charles University, Czech Republic First Faculty of Medicine, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201494
- Sponsor's protocol ID
- CZ-VFN-PEDMET-ASTHMA-001
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06201494
- Acronym / sponsor ID
- CZ-VFN-PEDMET-ASTHMA-001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with suspected diagnosis of asthma without any further chronic disease associated with respiratory symptoms.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jana Tukova, MD,PhD principal investigator
Charles University, Czech Republic First Faculty of Medicine, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Asthma in Children, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jana Tukova (+420608116653, tukovajana@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of typical and atypical asthma symptoms in children with asthma bronchiale (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.