Preventing asthma exacerbations by avoiding mite allergen
| ISRCTN | ISRCTN69543196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69543196 |
| Protocol serial number | 11078 |
| Sponsor | University Hospital of South Manchester NHS Foundation Trust (UK) |
| Funder | J P Moulton Charitable Foundation (UK) |
- 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
Scientific
University Hospital of South Manchester NHS Foundation Trust
Education and Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Exacerbation rate measured over 12 months from randomisation |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/03/2017: Publication reference added.
