Condition category
Respiratory
Date applied
25/07/2012
Date assigned
30/07/2012
Last edited
25/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Murray

ORCID ID

Contact details

University Hospital of South Manchester NHS Foundation Trust
Education and Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11078

Study information

Scientific title

Preventing asthma exacerbations in children by avoiding mite allergen

Acronym

Study hypothesis

Asthma is a common disease in children and for most symptoms are well controlled with regular inhaler medications. However, many will still experience exacerbations (times when their symptoms become out of control) and these will result in school absenteeism, visits to the GP or A&E and even hospital admission. Previous studies have identified risk factors for exacerbations and these include viral infections and exposure to allergens that the child is sensitised to. In fact these two factors together are the biggest risk factor of all. The commonest allergen asthmatic children are sensitised and exposed to in the UK is house dust mite (HDM) allergen. These mites live in our beds and bedding, carpets, curtains, soft toys and clothes. Close contact is most frequent at night from our bedding. We can reduce exposure to these allergens by installing miteproof bedding covers (mattress, pillow and duvet).The purpose of the study is to find out whether reducing exposure to HDM allergen by using miteimpermeable bedding covers will reduce the number of exacerbations an asthmatic child has over the following 12 months. We will test the bedding covers by comparing them to “placebo” (dummy) covers. To do this fairly we will allocate children randomly so that everybody has an equal chance of either receiving the mite impermeable bedding covers or receiving the “placebo” covers. Asthmatic children (3 - 17yrs old) will be recruited following an exacerbation of asthma from hospitals across the North West Region. Research staff will visit them in their homes following recovery, consent them to the study and install the bedding covers. Children will be followed 3 monthly for a further 12 months by telephone contact. Questionnaires will collect infromation on exacerbations, symptoms and quality of life.

Ethics approval

ref: 11/ NW/0262

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma in paediatrics

Intervention

Mite proof bedding covers

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Exacerbation rate measured over 12 months from randomisation

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2011

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children age 3-17 years with a physician diagnosis of asthma, following a recent exacerbation
2. Skin prick test positive to house dust mite (weal diameter 3mm or greater than the control)
3. Male or female participants

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 450; UK Sample Size: 450

Participant exclusion criteria

1. Using mite proof bedding prior to enrolling in the study
2. Significant other medical condition

Recruitment start date

01/11/2011

Recruitment end date

01/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.south.manchester.ac.uk/

Funders

Funder type

Charity

Funder name

J P Moulton Charitable Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes