The effect of mite allergen avoidance by the use of allergen impermeable bedding, on asthma control in adults
ISRCTN | ISRCTN27958413 |
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DOI | https://doi.org/10.1186/ISRCTN27958413 |
Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/12/2008
- 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
Prof Ashley Woodcock
Scientific
Scientific
Lung Function Unit
North West Lung Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | SMAC |
Study objectives | Asthma is an increasing clinical problem and allergy to indoor allergens is an important cause. The hypothesis that house dust mite allergen avoidance, by the use of allergen impermeable bedding, improves asthma control will be tested. The trial will assess over one year both the ability of this approach to improve lung function and quality of life whilst reducing symptoms and prn-beta-agonist use and, in the second six month period, the potential for a reduction in regular prophylactic maintenance therapy. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
Intervention | Asthmatic patients are randomly allocated to receive either active allergen-proof covers for mattress, duvet and pillows, or a set of dummy covers which look and feel similar to the allergen-proof covers but do not form a protective barrier. Covers remain on their beds for one year. |
Intervention type | Other |
Primary outcome measure | 1. Average morning peak expiratory flow rate in the four week period prior to the six month visit 2. Complete withdrawal from steroids in second six months |
Secondary outcome measures | 1. Use of beta agonist rescue medication and median symptom score in the four week period prior to the six month visit 2. Number of exacerbations in the six month period 3. Quality of life (St George's Respiratory Questionnaire and Short Form 36) at six month and twelve months 4. Cost of treatment and time off work (Health Care Questionnaire) 5. Change in dose of inhaled steroid in second six months |
Overall study start date | 01/05/1998 |
Completion date | 01/04/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 50 Years |
Sex | Not Specified |
Target number of participants | 1800 |
Key inclusion criteria | 1800 asthmatics ages 18-50 years at recruitment |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/05/1998 |
Date of final enrolment | 01/04/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lung Function Unit
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
NHS Asthma National Research and Development Programme (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 17/07/2003 | Yes | No |