Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 mei 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

46

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

5 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Ventilation
Increased ventilation in the childs bedroom to at least 2-3 air changes pr hour.
Apparaat: 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
Andere namen:
  • Ventilation units Type DUPLEX 370 EC4.D
Placebo-vergelijker: Placebo ventilation
Ventilation system that recirculates the air in the childs bedroom
Apparaat: 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.
Andere namen:
  • Placebo ventilation unit type DUPLEX 370

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in dose of inhaled corticosteroid
Tijdsspanne: 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
Tijdsspanne: baseline, 3 months, 6 months and 9 months
Measured as particles pr. m3
baseline, 3 months, 6 months and 9 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FEV1
Tijdsspanne: Baseline, 3,6 and 9 months
Forced Expiratory Volume after 1 second
Baseline, 3,6 and 9 months
FeNO
Tijdsspanne: Baseline, 3,6 and 9 months
Forced Expiratory Nitric Oxide
Baseline, 3,6 and 9 months
Quality of Life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 3, 6 and 9 months
Baseline, 3, 6 and 9 months
Ventilation rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline, 3, 6 and 9 months
Reduction in allergen levels.
baseline, 3, 6 and 9 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Aarhus

Onderzoekers

  • Studie directeur: Torben Sigsgaard, Professor, Aarhus University, Department of Public Health, Section for Environment, Occupation and Health
  • Hoofdonderzoeker: Nina V Hogaard, MD, Aarhus University, Dept. of Public Health, Section for Environment, Occupation and Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2012

Primaire voltooiing (Werkelijk)

1 februari 2016

Studie voltooiing (Werkelijk)

1 februari 2016

Studieregistratiedata

Eerst ingediend

19 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

19 februari 2014

Eerst geplaatst (Schatting)

21 februari 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

12 mei 2016

Laatste update ingediend die voldeed aan QC-criteria

11 mei 2016

Laatst geverifieerd

1 mei 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AstmaVen - 1101

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren