Asthma in ChildrenNCT05992389
Evidence Driven Indoor Air Quality Improvement
An observational study of Asthma in Children and Pollution; Exposure, run by Children's Hospital Srebrnjak at 1 site in Croatia.
Trial summary
The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes as well as certain disease outcomes and their relation to impaired indoor air quality. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Pollution; Exposure
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 3 Apr 2023to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Total of 200 children will be recruited for this study. 150 school aged children with asthma (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be recruited to this study. These participants will be recruited from the outpatient clinic at the Srebrnjak Children's Hospital in Zagreb, Croatia, as well as matching control participants (non-asthmatic subjects, N=50).
Who may be able to join
- school aged participants with asthma (patients with a clinical diagnosis of asthma (according to European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines) for at least a year , being on a stable dose of anti-inflammatory treatment for at least one month with partially controlled or uncontrolled asthma according to GINA guidelines)
- non-asthmatic school aged participants (matching control subjects)
- signed informed consent, .
- additional inclusion criteria include clinically significant allergy to indoor and outdoor allergens, with positive skin prick test (SPT) and specific IgE levels (>0.7 kUA/L) (UA = allergen-specific unit)
Who cannot join
- known inborn or perinatal pulmonary disease;
- pulmonary malformation;
- oxygen therapy after birth with a duration of more than 24h;
- ventilator support or mechanical ventilation after birth;
- diagnosis of cystic fibrosis;
- primary ciliary dyskinesia;
Show all 12Show fewer
- heart failure diagnosed after birth affecting pulmonary circulation;
- major respiratory diseases such as e.g. interstitial lung disease,
- acute respiratory infection at recruitment,
- use of systemic corticosteroids,
- recent asthma-related visit to emergency department (in the past three weeks)
- coexistence of other serious chronic illness. Moreover, children will be excluded from study visits and biomaterial collection in the case of fever of at least 38.5°C during the last two weeks prior to the planned visit.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Children's Hospital Srebrnjak
Zagreb, 10000
Mirjana Turkalj, MD, PhD, +38516391164, mturkalj@bolnica-srebrnjak.hr
Mirjana Turkalj, Prof,MD, PhD
About this study
The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes as well as certain disease outcomes and their relation to impaired indoor air quality. This may also help in underpinning specific target mechanisms in order to personalize and improve current treatment options in childhood asthma and develop more successful prevention strategies. This will be done by combining data from detailed clinical phenotyping with multiple -omics data.
Read the detailed description
A recent report from the European Environmental Agency (EEA) shows that as many as 417 000 deaths per year in large European cities are caused by long-term exposure to air pollution (EEA 2018). Children are more sensitive to environmental risks than adults. Environmental pollution (impaired air quality) has been linked to asthma development. Asthma is the most common chronic disease in children, with estimations that one in every five children will develop asthma during childhood. The effects of poor air quality most likely act synergistically with other predisposing and environmental factors, and in a cumulative manner. Additionally, asthma in children is considered to be a complex syndrome encompassing a number of different disease subtypes (phenotypes) driven by distinct yet discrete underlying pathophysiological mechanisms (endotypes). Detailed characterization of these pheno- and endotypes in asthma, as well as disease and treatment outcomes resulting from them still remain elusive.
The modern way of life, especially in the light of the COVID-19 ('CO' stands for corona, 'VI' for virus, 'D' for disease, and '19' for 2019 (year first identified)) pandemic, implies that people spend up to 90% of our time indoors. Certain studies suggest that indoor air quality may be significantly worse than outdoors and the regulation of indoor air quality falls much behind the legislative and guidelines in outdoor air quality. It is reasonable to believe that indoor air quality affects human health (risk for allergy, asthma, and specific disease subtypes) at least as much as outdoor pollutants, if not more.
For the Evidence Driven Indoor Air Quality Improvement Srebrnjak Children's Hospital (EDIAQI SCH 2021) cohort, 200 school aged children (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be recruited to this study from the outpatient clinic at the Srebrnjak Children's Hospital (SCH) in Zagreb, Croatia, which is the national Referral Centre of the Croatian Ministry of Health for Clinical Allergology in children.
150 of them with the diagnosed asthma and 50 participants their matching control, non-asthmatic subjects.
Following an expert (physician, experienced allergy/pulmonology specialist) confirmed diagnosis of asthma and after obtaining an informed consent from the children's caregivers/children themselves (according to local legislative), participants undergo a standard battery of diagnostic tests, examinations and procedures as a part of their routine asthma management plan. This study will also involve clinical follow-up visits (approximately every 3-6 months, according to Global Initiative for Asthma (GINA) guidelines). As a part of this research, certain biological samples (blood, exhaled breath condensate, induced sputum) will be collected both at baseline and follow-up visits, aiming at using biological samples left over from routine diagnostics whenever possible and using minimally invasive methods at all times.
The study will include visits:
- Initial (screening) visit (First patient first visit- V0 +3 months): written consent, assessment of inclusion and exclusion criteria, physical examination, anthropometric measurements, skin prick test (SPT), Specific Immunoglobulin E (sIgE) (+ISAC), Atopy patch test (APT), spirometry, fractional exhaled nitric oxide (FENO), questionnaires, blood sampling, buccal cells swabs, exhaled breath condensate (EBC), induced sputum
- First follow-up visit- V1 (V0 + 3-6 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Second follow-up visit- V2 (V0 + 6-12 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Third follow-up visit- V3 (V0 + 9-18 - months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Fourth follow-up visit (V0 + 21 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Last visit (last patient last visit- V0 + 24 months): anthropometric measurements, SPT, sIgE (+ISAC), APT, spirometry, FENO, questionnaires, blood sampling, buccal cells swabs, EBC, induced sputum, asthma control assessment, final assessment of the study outcome measures, check and document consumption, adherence, preventive measures.
- Conditions
- Asthma in Children, Pollution; Exposure
- Keywords
- indoor air quality, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with asthma | School aged participants (6-14 yrs) with an established diagnosis of asthma | |
| Non-asthmatic subjects (healthy control) | School aged participants (6-14 yrs), non-asthmatic subjects (negative history of allergic diseases) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of asthma exacerbations and severity
The exacerbation rate and exacerbation severity will be recorded along with the treatment use (reliever medication, use of oral and parenteral corticosteroids etc.) During the patient examination the questionnaire will be used to record the number of asthma exacerbations and the therapy used.
Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Measured: 6 months
Secondary outcomes (4)
Change of asthma control
Childhood Asthma Control Test (C-ACT) questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. For children 4 to 11 years maximal score is 27, and for those older then 12 years maximal score is 25. Higher scores reflect greater asthma control, and if the score is 19 or less may be a sign that asthma is not controlled as well as it could be.
Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Measured: 6 months
Lung function tests
Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC) will be recorded for each patient at each visit. Both FEV1 and FVC are measured in liters
FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Measured: 6 months
Fractional exhaled nitric oxide (FeNO)
FeNO test measures the level of nitric oxide gas in an exhaled sample of breath. It is measured in "parts per billion" (ppb).
Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Measured: 6 months
Use of controller medication
Type and dose of controller medication wil be monitored and recorded. Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start3 Apr 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Srebrnjak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjana Turkalj, MD, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992389
- Sponsor's protocol ID
- SCH-EU101057497
- Status last verified
- Aug 2023
- First submitted
- 12 May 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Driven Indoor Air Quality Improvement
- ClinicalTrials.gov ID
- NCT05992389
- Acronym / sponsor ID
- SCH-EU101057497
- Conditions
- Asthma in Children, Pollution; Exposure
- Keywords
- indoor air quality, asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital SrebrnjakUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes as well as certain disease outcomes and their relation to impaired indoor air quality. This may also help in underpinning specific target mechanisms in order to personalize and improve current treatment options in childhood asthma and develop more successful prevention strategies. This will be done by combining data from detailed clinical phenotyping with multiple -omics data.
Detailed description
A recent report from the European Environmental Agency (EEA) shows that as many as 417 000 deaths per year in large European cities are caused by long-term exposure to air pollution (EEA 2018). Children are more sensitive to environmental risks than adults. Environmental pollution (impaired air quality) has been linked to asthma development. Asthma is the most common chronic disease in children, with estimations that one in every five children will develop asthma during childhood. The effects of poor air quality most likely act synergistically with other predisposing and environmental factors, and in a cumulative manner. Additionally, asthma in children is considered to be a complex syndrome encompassing a number of different disease subtypes (phenotypes) driven by distinct yet discrete underlying pathophysiological mechanisms (endotypes). Detailed characterization of these pheno- and endotypes in asthma, as well as disease and treatment outcomes resulting from them still remain elusive.
The modern way of life, especially in the light of the COVID-19 ('CO' stands for corona, 'VI' for virus, 'D' for disease, and '19' for 2019 (year first identified)) pandemic, implies that people spend up to 90% of our time indoors. Certain studies suggest that indoor air quality may be significantly worse than outdoors and the regulation of indoor air quality falls much behind the legislative and guidelines in outdoor air quality. It is reasonable to believe that indoor air quality affects human health (risk for allergy, asthma, and specific disease subtypes) at least as much as outdoor pollutants, if not more.
For the Evidence Driven Indoor Air Quality Improvement Srebrnjak Children's Hospital (EDIAQI SCH 2021) cohort, 200 school aged children (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be recruited to this study from the outpatient clinic at the Srebrnjak Children's Hospital (SCH) in Zagreb, Croatia, which is the national Referral Centre of the Croatian Ministry of Health for Clinical Allergology in children.
150 of them with the diagnosed asthma and 50 participants their matching control, non-asthmatic subjects.
Following an expert (physician, experienced allergy/pulmonology specialist) confirmed diagnosis of asthma and after obtaining an informed consent from the children's caregivers/children themselves (according to local legislative), participants undergo a standard battery of diagnostic tests, examinations and procedures as a part of their routine asthma management plan. This study will also involve clinical follow-up visits (approximately every 3-6 months, according to Global Initiative for Asthma (GINA) guidelines). As a part of this research, certain biological samples (blood, exhaled breath condensate, induced sputum) will be collected both at baseline and follow-up visits, aiming at using biological samples left over from routine diagnostics whenever possible and using minimally invasive methods at all times.
The study will include visits:
- Initial (screening) visit (First patient first visit- V0 +3 months): written consent, assessment of inclusion and exclusion criteria, physical examination, anthropometric measurements, skin prick test (SPT), Specific Immunoglobulin E (sIgE) (+ISAC), Atopy patch test (APT), spirometry, fractional exhaled nitric oxide (FENO), questionnaires, blood sampling, buccal cells swabs, exhaled breath condensate (EBC), induced sputum
- First follow-up visit- V1 (V0 + 3-6 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Second follow-up visit- V2 (V0 + 6-12 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Third follow-up visit- V3 (V0 + 9-18 - months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Fourth follow-up visit (V0 + 21 months): questionnaires, spirometry, FENO, anthropometric measurements, asthma control assessment
- Last visit (last patient last visit- V0 + 24 months): anthropometric measurements, SPT, sIgE (+ISAC), APT, spirometry, FENO, questionnaires, blood sampling, buccal cells swabs, EBC, induced sputum, asthma control assessment, final assessment of the study outcome measures, check and document consumption, adherence, preventive measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with asthma | – | –School aged participants (6-14 yrs) with an established diagnosis of asthma |
| Non-asthmatic subjects (healthy control) | – | –School aged participants (6-14 yrs), non-asthmatic subjects (negative history of allergic diseases) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Total of 200 children will be recruited for this study. 150 school aged children with asthma (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be recruited to this study. These participants will be recruited from the outpatient clinic at the Srebrnjak Children's Hospital in Zagreb, Croatia, as well as matching control participants (non-asthmatic subjects, N=50).
Key inclusion criteria (4 listed)
- school aged participants with asthma (patients with a clinical diagnosis of asthma (according to European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines) for at least a year , being on a stable dose of anti-inflammatory treatment for at least one month with partially controlled or uncontrolled asthma according to GINA guidelines)
- non-asthmatic school aged participants (matching control subjects)
- signed informed consent, .
- additional inclusion criteria include clinically significant allergy to indoor and outdoor allergens, with positive skin prick test (SPT) and specific IgE levels (>0.7 kUA/L) (UA = allergen-specific unit)
Key exclusion criteria (12 listed)
- known inborn or perinatal pulmonary disease;
- pulmonary malformation;
- oxygen therapy after birth with a duration of more than 24h;
- ventilator support or mechanical ventilation after birth;
- diagnosis of cystic fibrosis;
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
Change in the number of asthma exacerbations and severity
Time frame: 6 months
The exacerbation rate and exacerbation severity will be recorded along with the treatment use (reliever medication, use of oral and parenteral corticosteroids etc.) During the patient examination the questionnaire will be used to record the number of asthma exacerbations and the therapy used. Asthmatic patients will be regularly controlled even more often in case of exacerbations.
4 secondary outcomes
Change of asthma control
Time frame: 6 months
Lung function tests
Time frame: 6 months
Fractional exhaled nitric oxide (FeNO)
Time frame: 6 months
Use of controller medication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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. This study is not recruiting at the moment.
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 in Children and Pollution; Exposure, run by Children's Hospital Srebrnjak at 1 site in Croatia.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjana Turkalj, Prof., MD (+38516391164, mturkalj@bolnica-srebrnjak.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of asthma exacerbations and severity (time frame: 6 months). 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 21 Aug 2023.