Condition category
Respiratory
Date applied
26/09/2005
Date assigned
19/10/2005
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adnan Custovic

ORCID ID

Contact details

North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2494
adnan.custovic@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Manchester Asthma and Allergy Study - primary prevention of asthma and allergy by allergen avoidance in high risk infants: a randomised controlled trial

Acronym

MAAS

Study hypothesis

Living in a low allergen environment reduces the risk of primary sensitisation and the development of atopic disease in children at high risk

Ethics approval

South Manchester Research Ethics Committee, 24/03/1994, ref: WJP/CMI/ERP/94/032

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

House dust mite allergen avoidance versus no intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Asthma at age 5, 8, 11, and 14 years
2. Sensitisation at age 1, 3, 5, 8, 11 and 14 years

Secondary outcome measures

Wheeze and eczema at age 1, 3, 5, 8, 11 and 14 years

Overall trial start date

01/09/1995

Overall trial end date

01/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

High-risk children (both parents atopic) of either sex born at Wythenshawe Hospital Manchester and Stepping Hill Hospital Stockport between January 1996 and April 1998

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant exclusion criteria

Premature birth less than 32 weeks gestation

Recruitment start date

01/09/1995

Recruitment end date

01/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Wythenshawe Hospital (UK)

Sponsor details

c/o Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5775
andrew.maines@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Asthma UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Moulton Charitable Trust (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

2001 results in: http://www.ncbi.nlm.nih.gov/pubmed/11476835
2004 environmental control results in: http://www.ncbi.nlm.nih.gov/pubmed/15142868

Publication citations

  1. Results

    Custovic A, Simpson BM, Simpson A, Kissen P, Woodcock A, , Effect of environmental manipulation in pregnancy and early life on respiratory symptoms and atopy during first year of life: a randomised trial., Lancet, 2001, 358, 9277, 188-193, doi: 10.1016/S0140-6736(01)05406-X.

  2. Environmental control results

    Woodcock A, Lowe LA, Murray CS, Simpson BM, Pipis SD, Kissen P, Simpson A, Custovic A, , Early life environmental control: effect on symptoms, sensitization, and lung function at age 3 years., Am. J. Respir. Crit. Care Med., 2004, 170, 4, 433-439, doi: 10.1164/rccm.200401-083OC.

Additional files

Editorial Notes