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AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children (AsthmaVent)

11 mai 2016 mis à jour par: University of Aarhus

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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:

  1. An increased ventilation in the home will reduce the need for inhaled steroids in children with house dust mite allergy and asthma.
  2. An increased ventilation in the home will improve the quality of life in children with house dust mite allergy and asthma.
  3. 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.

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.

Type d'étude

Interventionnel

Inscription (Réel)

46

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
    • Region Hovedstaden
      • Herlev, Region Hovedstaden, Danemark, 2730
        • Børneafdelingen Herlev Hospital
    • Region Midt
      • Aarhus, Region Midt, Danemark, 8200
        • Childrens Department, Aarhus University Hospital
      • Herning, Region Midt, Danemark, 7400
        • Childrens Department, Herning Hospital
      • Randers, Region Midt, Danemark, 8930
        • Childrens DEpartment, Randers Hospital
    • Region Nordsjælland
      • Hillerød, Region Nordsjælland, Danemark, 3400
        • Childrens Department, Hillerød hospital
    • Region Syddanmark
      • Kolding, Region Syddanmark, Danemark, 6000
        • Childrens Department, Kolding Hospital
      • Odense, Region Syddanmark, Danemark, 5000
        • H.C. Andersens Children Hospital, Odense University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Ventilation
Increased ventilation in the childs bedroom to at least 2-3 air changes pr hour.
Dispositif: Ventilation
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
Autres noms:
  • Ventilation units Type DUPLEX 370 EC4.D
Comparateur placebo: Placebo ventilation
Ventilation system that recirculates the air in the childs bedroom
Dispositif: Placebo Ventilation
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.
Autres noms:
  • Placebo ventilation unit type DUPLEX 370

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in dose of inhaled corticosteroid
Délai: Baseline, 3 months, 6 months and 9 months
Measured in micrograms of a specific inhaled corticosteroid
Baseline, 3 months, 6 months and 9 months
Changes in particle concentration in child bedroom
Délai: baseline, 3 months, 6 months and 9 months
Measured as particles pr. m3
baseline, 3 months, 6 months and 9 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
FEV1
Délai: Baseline, 3,6 and 9 months
Forced Expiratory Volume after 1 second
Baseline, 3,6 and 9 months
FeNO
Délai: Baseline, 3,6 and 9 months
Forced Expiratory Nitric Oxide
Baseline, 3,6 and 9 months
Quality of Life
Délai: Baseline, 3,6 and 9 months
Pediatric Asthma Quality of Life Questionaire
Baseline, 3,6 and 9 months
Standard Skin-prick-test and Specific IgE- phadiatop
Délai: 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.
Baseline and 9 months
Asthma Symptoms
Délai: During 14 days at baseline, 3, 6 and 9 months
Assessed from a Symptom score scheme
During 14 days at baseline, 3, 6 and 9 months
Peakflow variability
Délai: Baseline, 3, 6 and 9 months
Baseline, 3, 6 and 9 months
Ventilation rate
Délai: Baseline, 3, 6 and 9 months
Ventilation rate in the childs bedroom and in the Whole house
Baseline, 3, 6 and 9 months
Physical conditions in the child bedroom and whole house
Délai: baseline, 3 6 and 9 months
Changes in temperature and humidity
baseline, 3 6 and 9 months
Allergens in child mattress and airborne in child bedroom
Délai: baseline, 3, 6 and 9 months
Reduction in allergen levels.
baseline, 3, 6 and 9 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Aarhus

Les enquêteurs

  • Directeur d'études: Torben Sigsgaard, Professor, Aarhus University, Department of Public Health, Section for Environment, Occupation and Health
  • Chercheur principal: Nina V Hogaard, MD, Aarhus University, Dept. of Public Health, Section for Environment, Occupation and Health

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2012

Achèvement primaire (Réel)

1 février 2016

Achèvement de l'étude (Réel)

1 février 2016

Dates d'inscription aux études

Première soumission

19 février 2014

Première soumission répondant aux critères de contrôle qualité

19 février 2014

Première publication (Estimation)

21 février 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AstmaVen - 1101

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