MAPS: 6 -YEAR FOLLOW UP
Research type
Research Study
Full title
Primary prevention of atopy and asthma with house dust mite sublingual immunotherapy: 6 years follow up.
IRAS ID
204152
Contact name
Hasan Arshad
Contact email
Sponsor organisation
University Hospital Southampton
Duration of Study in the UK
1 years, 0 months, days
Research summary
There is an epidemic of allergic disease in childhood and current preventative strategies have failed to demonstrate effectiveness outside of isolated trials. In a previous MAPS study, the efficacy of sublingual immunotherapy (SLIT) with
house dust mite (HDM) in preventing the development of allergic sensitisation in infants was assessed. The long-term objective was to assess the effect of the intervention on the subsequent development of asthma. A total of 111 infants
at high risk of allergy (with ≥2 first degree relatives affected by asthma or allergy) but with no evidence of allergic sensitisation at recruitment were recruited. These infants were randomised at 6 months of age to receive a year of active HDM allergen extract delivered as SLIT or placebo intervention. Allergic sensitisation and allergic disease status was assessed at 18 months of age.
This study is the 6 year follow up of this interventional cohort. The aim of the 6 year assessment is to assess the efficacy of prophylactic oral immunotherapy with HDM allergen in preventing the development of allergic sensitisation.
The hypothesis is that high dose oral immunotherapy will induce immune tolerance and reduce development of allergic sensitisation and later clinical asthma and allergy. Participants will be assessed 4 years after finishing the intervention. The assessment will include a questionnaire and skin prick testing to the common aeroallergens and food allergens. Families and study investigators will both be blinded to participants’ original treatment allocations.This study will also follow up the participants from the ITEC study, this study looked at how a child's environment affects the way the newborn immune system reacts to common allergens in the environment.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0217
Date of REC Opinion
15 Aug 2016
REC opinion
Further Information Favourable Opinion