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Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma - Article


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Mite (Sarcoptes scabei) Infestation

 




Clinical Trial: Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma

This study is currently recruiting patients.
Verified by University of Glasgow June 2005

Sponsors and Collaborators: University of Glasgow
Chief Scientist''''s Office of the Scottish Executive
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

Purpose

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 November 2006.

Condition Intervention Phase
Asthma
 Device: Mechanical Heat Recovery Ventilation
Phase II

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Randomised Controlled Trial of Mechanical Heat Recovery Ventilation on Asthma Control of Patients Allergic to the House Dust Mite

Further Study Details: 
Primary Outcomes: morning Peak Flow
Secondary Outcomes: symptom scores; exacerbation rates; quality of life; spirometry
Expected Total Enrollment:  140

Study start: February 2003;  Expected completion: February 2007
Last follow-up: November 2006;  Data entry closure: December 2006

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.

Eligibility

Ages Eligible for Study:  16 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148096

Gillian R Vallance, BM BCh      0141 211 1673    gv10y@clinmed.gla.ac.uk
Joyce Thompson      0141 330 8350    jt80t@clinmed.gla.ac.uk

United Kingdom
      Monklands General Hospital, North Lanarkshire,  United Kingdom; Recruiting
Gillian R Vallance, BM BCh  01236 712755    gv10@clinmed.gla.ac.uk 
Dr Lawrence McAlpine, MB ChB,  Principal Investigator

Study chairs or principal investigators

Prof Neil C Thomson, MD FRCP,  Principal Investigator,  The University of Glasgow   

More Information

Study ID Numbers:  CZB/4/47; CSO CZB/4/47 and BO/01/69
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00148096
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13

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