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 beds and bedding, carpets, curtains, soft toys and clothes. Close contact is most frequent at night from our bedding. Exposure to these allergens can be reduced 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.
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 to request a patient information sheet
Condition
Asthma in paediatrics
Intervention
The bedding covers will be tested by comparing them to placebo (dummy) covers. To do this fairly children will be randomly allocated so that everybody has an equal chance of either receiving the mite impermeable bedding covers or receiving the placebo covers. Asthmatic children (3 - 17 years 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.
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
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
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28282501