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Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma

NCT ID: NCT00148096

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Keywords

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asthma house dust mite allergy housing avoidance humidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Mechanical heat recovery ventilation units installed but not fully functional

Group Type PLACEBO_COMPARATOR

Mechanical Heat Recovery Ventilation

Intervention Type DEVICE

De-humidification without loss of heat

2

Mechanical heat recovery ventilation unit installed and active

Group Type ACTIVE_COMPARATOR

Mechanical Heat Recovery Ventilation

Intervention Type DEVICE

De-humidification without loss of heat

Interventions

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Mechanical Heat Recovery Ventilation

De-humidification without loss of heat

Intervention Type DEVICE

Other Intervention Names

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Ventaxia

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role collaborator

North Lanarkshire Council

UNKNOWN

Sponsor Role collaborator

South Lanarkshire Council

UNKNOWN

Sponsor Role collaborator

North Glasgow Primary Care Trust

UNKNOWN

Sponsor Role collaborator

Vent-axia Ltd

UNKNOWN

Sponsor Role collaborator

Scottish Power

UNKNOWN

Sponsor Role collaborator

Energy Action Scotland

UNKNOWN

Sponsor Role collaborator

Communities Scotland

UNKNOWN

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role lead

Principal Investigators

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Prof Neil C Thomson, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

The University of Glasgow

Locations

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Monklands General Hospital

North Lanarkshire, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.gla.ac.uk/departments/immunology/respiratorymedicine/

Asthma Research Unit website

Other Identifiers

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CSO CZB/4/47 and BO/01/69

Identifier Type: -

Identifier Source: secondary_id

CZB/4/47

Identifier Type: -

Identifier Source: org_study_id