NCT00148096

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 24, 2009

Status Verified

November 1, 2007

First QC Date

September 2, 2005

Last Update Submit

December 23, 2009

Conditions

Asthma

Keywords

asthmahouse dust miteallergyhousingavoidancehumidity

Outcome Measures

Primary Outcomes (1)

  • morning Peak Flow

    1 year

Secondary Outcomes (4)

  • symptom scores

    1 year

  • exacerbation rates

    1 year

  • quality of life

    1 year

  • spirometry

    1 year

Study Arms (2)

1

PLACEBO COMPARATOR

Mechanical heat recovery ventilation units installed but not fully functional

Device: Mechanical Heat Recovery Ventilation

2

ACTIVE COMPARATOR

Mechanical heat recovery ventilation unit installed and active

Device: Mechanical Heat Recovery Ventilation

Interventions

Mechanical Heat Recovery VentilationDEVICE

De-humidification without loss of heat

Also known as: Ventaxia
12

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Multi-storey flat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monklands General Hospital

North Lanarkshire, United Kingdom

Location

Related Links

MeSH Terms

Conditions

AsthmaHypersensitivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Prof Neil C Thomson, MD FRCP

    The University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

February 1, 2003

Study Completion

April 1, 2007

Last Updated

December 24, 2009

Record last verified: 2007-11

Locations

GB(1)