Status:
UNKNOWN
Evidence Driven Indoor Air Quality Improvement
Lead Sponsor:
Children's Hospital Srebrnjak
Conditions:
Asthma in Children
Pollution; Exposure
Eligibility:
All Genders
6-14 years
Brief 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. This may also help in...
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). Childr...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
April 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05992389
Start Date
April 3 2023
End Date
April 1 2025
Last Update
August 21 2023
Active Locations (1)
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1
Children's Hospital Srebrnjak
Zagreb, Croatia, 10000