AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 14
- 主要终点
- Changes in dose of inhaled corticosteroid
研究概览
简要总结
AsthmaVent is a multi-center study, investigating the association between indoor air quality and childhood asthma.
In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever before. We know that indoor air contains many different components that can affect our airways inappropriately and particularly children with asthma, who have sensitive airways are sensitive to these components. The AsthmaVent project examines whether increased ventilation is able to improve the indoor environment to such an extent that the asthma disease control, for children with asthma and house dust mite allergy improves, resulting in need for less medication.
Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both the indoor air quality and on children's health and quality of life. There is not currently a consensus in this area, as studies so far have not been large or good enough to confidently determine the effect.
This project is big and is designed so that it takes into account the sources of error seen in previous studies on the topic.
We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding, Randers and Herning. They are divided into two groups, receiving either active ventilation or placebo ventilation, meaning a non-functioning ventilation system that just recirculates the air in the room. Ventilation systems are installed in the fall and winter and ventilate the child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3 months, both at home visits were air quality and allergen levels of house dust mites are studies and at visits to the outpatient clinics with control of asthma parameters and quality of life.
The project involves collaboration between several institutions with an interest in indoor air quality in relation to allergies and asthma and with great expertise in the field.The project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a center consisting of several institutions in Denmark dealing with indoor environment: Department of Public Health at Aarhus University and University of Copenhagen, Danish Building Research Institute and the Technical University of Denmark.
Since asthma is the most common chronic childhood disease in Denmark and since the development of allergies and asthma has high social and personal costs, it is important for both society and the individual family, to find out whether simply improving the indoor air quality by increased ventilation can lead to an improvement in asthma disease control.
详细描述
The aim of the project is to investigate whether increased ventilation is able to improve the indoor air quality and thereby asthma disease control for children with asthma and house dust mite allergy.
Hypotheses:
- An increased ventilation in the home will reduce the need for inhaled steroids in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the quality of life in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the indoor environment and thus improve asthma disease control in children with house dust mite allergy and asthma.
Materials and methods: The study is a randomized double-blind placebo-controlled intervention study. The intervention is balanced mechanical ventilation in the bedroom of children with asthma and house dust mite allergy during 9-months.
Population: Over 3 year period (2012-2014) 80 families with asthmatic children aged 6-18 years will be included from out-patient clinics at the children's department of the University Hospitals of Aarhus and Odense and regional hospitals in Kolding, Randers and Herning. Families will also be included from private pediatric clinics in Aarhus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Doctors diagnosed asthma
- •Need of inhaled steroid titrated down to at least 400 microg/day of Budesonide or equivalent dose of other corticosteroid
- •Skin prick test >/= 3 mm or specific IgE >/= 0,7 kU/l to house dust mites (Derm. Pteronyssinus and/or Derm. Farinae)
- •more than 500 nanog/gr dust of house dust mite allergen in the childs mattress.
- •Living in a one-family house and will allow changes of the house during the intervention period.
- •Capable of giving informed consent.
排除标准
- •Other clinically relevant allergies to tree pollen or animals present in the house.
- •Other diseases or treatments, as for example immunotherapy, which could influence the results.
结局指标
主要结局
Changes in dose of inhaled corticosteroid
时间窗: Baseline, 3 months, 6 months and 9 months
Measured in micrograms of a specific inhaled corticosteroid
Changes in particle concentration in child bedroom
时间窗: baseline, 3 months, 6 months and 9 months
Measured as particles pr. m3
次要结局
- FEV1(Baseline, 3,6 and 9 months)
- FeNO(Baseline, 3,6 and 9 months)
- Quality of Life(Baseline, 3,6 and 9 months)
- Standard Skin-prick-test and Specific IgE- phadiatop(Baseline and 9 months)
- Ventilation rate(Baseline, 3, 6 and 9 months)
- Physical conditions in the child bedroom and whole house(baseline, 3 6 and 9 months)
- Allergens in child mattress and airborne in child bedroom(baseline, 3, 6 and 9 months)
- Asthma Symptoms(During 14 days at baseline, 3, 6 and 9 months)
- Peakflow variability(Baseline, 3, 6 and 9 months)