Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
09/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ashley Woodcock

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes