Manchester Asthma and Allergy Study - primary prevention of asthma and allergy by allergen avoidance in high risk infants

ISRCTN	ISRCTN63558189
DOI	https://doi.org/10.1186/ISRCTN63558189
Protocol serial number	N/A
Sponsor	Wythenshawe Hospital (UK)
Funders	Asthma UK (UK), Moulton Charitable Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Adnan Custovic
Scientific

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

Phone	+44 (0)161 291 2494
Email	adnan.custovic@manchester.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Manchester Asthma and Allergy Study - primary prevention of asthma and allergy by allergen avoidance in high risk infants: a randomised controlled trial
Study acronym	MAAS
Study objectives	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(s)	South Manchester Research Ethics Committee, 24/03/1994, ref: WJP/CMI/ERP/94/032
Health condition(s) or problem(s) studied	Asthma
Intervention	House dust mite allergen avoidance versus no intervention.
Intervention type	Other
Primary outcome measure(s)	1. Asthma at age 5, 8, 11, and 14 years 2. Sensitisation at age 1, 3, 5, 8, 11 and 14 years
Key secondary outcome measure(s)	Wheeze and eczema at age 1, 3, 5, 8, 11 and 14 years
Completion date	01/06/2019

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	300
Key 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
Key exclusion criteria	Premature birth less than 32 weeks gestation
Date of first enrolment	01/09/1995
Date of final enrolment	01/06/2019

Wythenshawe Hospital

Manchester
M23 9LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/07/2001		Yes	No
Results article	environmental control results	15/08/2004		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

01/08/2017: internal review