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Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma

This study has been completed.
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
North Lanarkshire Council
South Lanarkshire Council
North Glasgow Primary Care Trust
Vent-axia Ltd
Scottish Power
Energy Action Scotland
Communities Scotland
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00148096
First received: September 2, 2005
Last updated: December 23, 2009
Last verified: November 2007

September 2, 2005
December 23, 2009
February 2003
Not Provided
morning Peak Flow [ Time Frame: 1 year ]
morning Peak Flow
Complete list of historical versions of study NCT00148096 on ClinicalTrials.gov Archive Site
  • symptom scores [ Time Frame: 1 year ]
  • exacerbation rates [ Time Frame: 1 year ]
  • quality of life [ Time Frame: 1 year ]
  • spirometry [ Time Frame: 1 year ]
  • symptom scores
  • exacerbation rates
  • quality of life
  • spirometry
Not Provided
Not Provided
 
Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma
Randomised Controlled Trial of Mechanical Heat Recovery Ventilation on Asthma Control of Patients Allergic to the House Dust Mite

Asthma has become increasingly common in the UK, demanding our consideration of the cause. Many patients with asthma are allergic to house dust mites, which thrive in modern housing. Improving ventilation in the home has been shown to reduce dust mite levels, by reducing humidity levels. It is hoped that, by removing the dust mites from homes, asthma may improve. In this study, 140 volunteers will have their carpets steam-cleaned and new allergy bedding provided, before a team of architects installs a ventilation system in the loft. Half of the units will be switched on at the beginning of the study. The other half will be switched on in 12 months time, but only the architects know which units are active. The medical team will compare the asthma, and measures of inflammation in the airways, over that year.

It is due for completion in April 2007.

The prevalence of asthma is rising sharply in the UK. The house dust mite is the most common trigger associated with asthma, thriving in the humid microclimate favoured by modern housing. Could this be redressed by investment in improved ventilation in local housing? In a pilot study in North Lanarkshire Council housing stock, we demonstrated that dust mite avoidance, in combination with installation of domestic mechanical heat recovery ventilation (MHRV), could inhibit the re-colonisation of house dust mites by reduction of indoor air humidity. In this second phase, a double blind randomized placebo- controlled trial will test the resultant effect on asthma. It will be complete in November 2006. 140 patients with asthma and house dust mite allergy are being recruited and all will have new bedding, mattress covers and carpets cleaned. All will have MHRV units installed in their home, but only half will be activated, before 12 months of environmental and clinical monitoring. The primary endpoint is morning peak flow rate. Secondary endpoints include symptom scores, spirometry, rates of exacerbations, quality-of-life, and economic evaluations. Demonstration that well ventilated, energy efficient dwellings improve the respiratory health of patients with allergic asthma could be of considerable importance in helping the NHS cope with the commonest chronic disease in Scotland.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
Device: Mechanical Heat Recovery Ventilation
De-humidification without loss of heat
Other Name: Ventaxia
  • Placebo Comparator: 1
    Mechanical heat recovery ventilation units installed but not fully functional
    Intervention: Device: Mechanical Heat Recovery Ventilation
  • Active Comparator: 2
    Mechanical heat recovery ventilation unit installed and active
    Intervention: Device: Mechanical Heat Recovery Ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
April 2007
Not Provided

Inclusion Criteria:

  • House dust mite sensitive
  • FEV1 greater than 50%
  • Symptomatic asthma or 12% reversibility on spirometry or 15%PEFR lability

Exclusion Criteria:

  • Multi-storey flat
Both
16 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00148096
CZB/4/47, CSO CZB/4/47 and BO/01/69
No
Not Provided
University of Glasgow
  • Chief Scientist Office of the Scottish Government
  • North Lanarkshire Council
  • South Lanarkshire Council
  • North Glasgow Primary Care Trust
  • Vent-axia Ltd
  • Scottish Power
  • Energy Action Scotland
  • Communities Scotland
Principal Investigator: Prof Neil C Thomson, MD FRCP The University of Glasgow
University of Glasgow
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP