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RecruitingNCT06201494Updated Jul 14, 2026

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

An observational study in Asthma, Asthma in Children and Dyspnea, sponsored by Charles University, Czech Republic. Recruiting at 1 site in Czechia. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Charles University, Czech Republic · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 80 is below the median of 158 across 1,250 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: After completion of study and its publication. For 5 years.

Access criteria: Proposals should be submitted to jana.tukova@vfn.cz.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.

Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's planned 47 months is above that.

Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2023
First posted
Jan 11, 2024
StartActual
Jan 1, 2023
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jun 1, 2027
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06201494
Responsible party
Jana Tuková (MUDr, Phd, Charles University, Czech Republic) — Principal investigator
First posted
Jan 11, 2024
Start date
Jan 1, 2023
Primary completion
Dec 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

Jana Tukova
Contact
tukovajana@seznam.cz
+420608116653
Jana Tukova, MD,PhD
principal investigator · Charles University, Czech Republic First Faculty of Medicine, Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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