AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children

NCT02068573 | Completed DMC

• 1 other identifier: AstmaVen - 1101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Childhood Asthma; Allergy

Keywords

Childhood Asthma; Allergy; House dust mites; Indoor air quality

Outcome Measures

Primary Outcomes (2)

• Changes in dose of inhaled corticosteroid

  Measured in micrograms of a specific inhaled corticosteroid

  Baseline, 3 months, 6 months and 9 months

• Changes in particle concentration in child bedroom

  Measured as particles pr. m3

  baseline, 3 months, 6 months and 9 months

Secondary Outcomes (9)

• 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

• Asthma Symptoms

  During 14 days at baseline, 3, 6 and 9 months

Study Arms (2)

Ventilation

ACTIVE COMPARATOR

Increased ventilation in the childs bedroom to at least 2-3 air changes pr hour.

Device: Ventilation

Placebo ventilation

PLACEBO COMPARATOR

Ventilation system that recirculates the air in the childs bedroom

Device: Placebo Ventilation

Interventions

Ventilation DEVICE

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

Also known as: Ventilation units Type DUPLEX 370 EC4.D

Ventilation

Placebo Ventilation DEVICE

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.

Also known as: Placebo ventilation unit type DUPLEX 370

Placebo ventilation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (7)

Børneafdelingen Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Location

Childrens Department, Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

Location

Childrens Department, Herning Hospital

Herning, Region Midt, 7400, Denmark

Location

Childrens DEpartment, Randers Hospital

Randers, Region Midt, 8930, Denmark

Location

Childrens Department, Hillerød hospital

Hillerød, Region Nordsjælland, 3400, Denmark

Location

Childrens Department, Kolding Hospital

Kolding, Region Syddanmark, 6000, Denmark

Location

H.C. Andersens Children Hospital, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Torben Sigsgaard, Professor

  Aarhus University, Department of Public Health, Section for Environment, Occupation and Health

  STUDY DIRECTOR

• Nina V Hogaard, MD

  Aarhus University, Dept. of Public Health, Section for Environment, Occupation and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: August 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

DK (7)