Preventing asthma exacerbations by avoiding mite allergen

ISRCTN	ISRCTN69543196
DOI	https://doi.org/10.1186/ISRCTN69543196
Secondary identifying numbers	11078

Submission date: 25/07/2012
Registration date: 30/07/2012
Last edited: 13/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Clare Murray
Scientific

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

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Preventing asthma exacerbations in children by avoiding mite allergen
Study objectives	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(s)	ref: 11/ NW/0262
Health condition(s) or problem(s) studied	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
Primary outcome measure	Exacerbation rate measured over 12 months from randomisation
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/11/2011
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	17 Years
Sex	Both
Target number of participants	Planned Sample Size: 450; UK Sample Size: 450
Key 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
Key exclusion criteria	1. Using mite proof bedding prior to enrolling in the study 2. Significant other medical condition
Date of first enrolment	01/11/2011
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital of South Manchester NHS Foundation Trust

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website	http://www.south.manchester.ac.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Charity

J P Moulton Charitable Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/07/2017		Yes	No

Editorial Notes

13/03/2017: Publication reference added.