Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SMAC
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/05/1998
Overall trial end date
01/04/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1800 asthmatics ages 18-50 years at recruitment
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1800
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/1998
Recruitment end date
01/04/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lung Function Unit
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Asthma National Research and Development Programme (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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12867606
Publication citations
-
Results
Woodcock A, Forster L, Matthews E, Martin J, Letley L, Vickers M, Britton J, Strachan D, Howarth P, Altmann D, Frost C, Custovic A, , Control of exposure to mite allergen and allergen-impermeable bed covers for adults with asthma., N. Engl. J. Med., 2003, 349, 3, 225-236, doi: 10.1056/NEJMoa023175.