Evidence Driven Indoor Air Quality Improvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in the number of asthma exacerbations and severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Change in the number of asthma exacerbations and severity
时间窗: 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.
次要结局
- Fractional exhaled nitric oxide (FeNO)(6 months)
- Use of controller medication(6 months)
- Lung function tests(6 months)
- Change of asthma control(6 months)
研究者
Mirjana Turkalj, MD
Professor, MD, PhD
Children's Hospital Srebrnjak