PRIMARY PREVENTION OF ATOPY AND ASTHMA WITH ALLERGEN SUBLINGUAL IMMUNOTHERAPY - Mite allergy prevention study (MAPS)
- Conditions
- Development of atopyMedDRA version: 12.1 Level: LLT Classification code 10019857 Term: Hereditary allergy
- Registration Number
- EUCTR2009-015679-28-GB
- Lead Sponsor
- Southampton University Hospitals Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria: Infants aged 5 to 9 months at high risk of development of asthma and atopy, as defined by two or more first degree relatives (i.e. biological mother, father or sibling) affected by asthma or allergy, assessed through standardised questionnaires.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Infants with positive skin test to one or more of 6 common allergens (house dust mite, grass pollen, cat, cows’ milk, egg white and peanut), prior to randomization at the age of 6-9 months, will be excluded. Following initial agreement and consent of the parents, skin prick test will be performed (in duplicate for house dust mite), on the volar surface of the forearm of the infant, using standardised methodology. A mean wheal diameter of =3mm when compared with saline control will be regarded as positive, the infant will be considered sensitized and excluded from the study. Infants with major concurrent health problems (e.g. congenital heart disease, cystic fibrosis, those requiring special feeding regimens on account of prematurity or illness) will be also be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method