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 | 
| Secondary identifying numbers | N/A | 
- Submission date
 - 26/09/2005
 - Registration date
 - 19/10/2005
 - Last edited
 - 01/08/2017
 
- 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 Adnan Custovic
Scientific
                                        Scientific
                                                North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
                                                
| Phone | +44 (0)161 291 2494 | 
|---|---|
| adnan.custovic@manchester.ac.uk | 
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Other | 
| Study type | Prevention | 
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/1995 | 
| Completion date | 01/06/2019 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Child | 
| Sex | All | 
| Target number of participants | 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 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            Wythenshawe Hospital
                                        
                                        
                                            
                                            Manchester
M23 9LT
United Kingdom
                                    M23 9LT
United Kingdom
Sponsor information
                                            Wythenshawe Hospital (UK)
Hospital/treatment centre
                                        Hospital/treatment centre
                                                c/o Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
                                                
| Phone | +44 (0)161 291 5775 | 
|---|---|
| andrew.maines@manchester.ac.uk | |
| https://ror.org/05vpsdj37 | 
Funders
Funder type
Charity
                                                Asthma UK (UK)
                                                
Private sector organisation / Research institutes and centers
                                            Private sector organisation / Research institutes and centers
- Alternative name(s)
 - asthmalunguk, Asthma UK, Asthma + Lung UK
 - Location
 - United Kingdom
 
                                                Moulton Charitable Trust (UK)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | |
| Publication and dissemination plan | 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 | 21/07/2001 | Yes | No | |
| Results article | environmental control results | 15/08/2004 | Yes | No | 
Editorial Notes
01/08/2017: internal review