NCT Number: NCT02068573
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.
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Notify Me5 year–18 year
All sexes
Interventional
Not applicable
Børneafdelingen Herlev Hospital, Herlev, Capital Region, Denmark
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:
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.
Randomization: After inclusion children are randomized to either active ventilation or placebo ventilation. Randomization is done in blocks of 4 by center.
Intervention: The ventilation units Type DUPLEX 370 EC4.D and DUPLEX 370 are installed during the fall and run continuously for 9 months. The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour. The placebo unit (DUPLEX 370) is a completely similar installation which only recirculates the air in the room instead of replacing it. We recommend all parents to wash the duvet and pillow every 3 months.
Data collection:
Data on the children's health is collected every 3 months when the families visit the outpatient clinics. The children are seen by specialist doctors.
At home visits, also every 3 months, data concerning the indoor air quality is collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour
Other names: Ventilation units Type DUPLEX 370 EC4.D
The placebo unit (DUPLEX 370) is a completely similar installation to the active ventilation unit, but it only recirculates the air in the room instead of replacing it with fresh conditioned air.
Other names: Placebo ventilation unit type DUPLEX 370
Time frame: Baseline, 3 months, 6 months and 9 months
Measured in micrograms of a specific inhaled corticosteroid
Time frame: baseline, 3 months, 6 months and 9 months
Measured as particles pr. m3
Time frame: Baseline, 3,6 and 9 months
Forced Expiratory Volume after 1 second
Time frame: Baseline, 3,6 and 9 months
Forced Expiratory Nitric Oxide
Time frame: Baseline, 3,6 and 9 months
Pediatric Asthma Quality of Life Questionaire
Time frame: Baseline and 9 months
Reduction in diameter of skin-prick-test for standard inhalant allergens and reduction in specific IgE for standard inhalant allergens measured in kU/l.
Time frame: During 14 days at baseline, 3, 6 and 9 months
Assessed from a Symptom score scheme
Time frame: Baseline, 3, 6 and 9 months
Time frame: Baseline, 3, 6 and 9 months
Ventilation rate in the childs bedroom and in the Whole house
Time frame: baseline, 3 6 and 9 months
Changes in temperature and humidity
Time frame: baseline, 3, 6 and 9 months
Reduction in allergen levels.
University of Aarhus
Other
Acronym: AsthmaVent
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