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
Protocol serial number	N/A
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Asthma National Research and Development Programme (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/04/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Lung Function Unit

Manchester
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	17/07/2003		Yes	No