The effect of mite allergen avoidance by the use of allergen impermeable bedding, on asthma control in adults

ISRCTN ISRCTN27958413
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

Lung Function Unit
North West Lung Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymSMAC
Study objectivesAsthma 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) studiedRespiratory tract diseases: Asthma
InterventionAsthmatic 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/05/1998
Completion date01/04/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexNot Specified
Target number of participants1800
Key inclusion criteria1800 asthmatics ages 18-50 years at recruitment
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/1998
Date of final enrolment01/04/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Lung Function Unit
Manchester
M23 9LT
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Asthma National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/07/2003 Yes No