Mite allergy prevention study (MAPS)

• Research type

  Research Study

• Full title

  PRIMARY PREVENTION OF ATOPY AND ASTHMA WITH ALLERGEN SUBLINGUAL IMMUNOTHERAPY

• IRAS ID

  10109

• Contact name

  Syed Hasan Arshad

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2009-015679-28

• ISRCTN Number

  n/a

• Research summary

  The increase in prevalence of asthma and allergic disease makes it imperative that new ways are found to prevent this increase and reduce the overall burden. In a previous study, we found that minimising exposure in infancy to food and house-dust mite allergens reduces the likelihood of at risk children developing asthma by about 50%. This approach, therefore, seems to be effective, but the comprehensive and extensive allergen avoidance measures required, are not applicable in a clinical setting or on a large scale. Since then, it has been shown that the relationship of allergen exposure and sensitisation is of a bell-shaped curve with minimal and large exposure leading to tolerance, while mid-level exposure causing allergic sensitisation. The proposed project will investigate if high level of exposure to house-dust mite allergen reduces the likelihood of atopy and asthma. We plan to recruit 120 infants, aged 6 months and at risk of asthma and allergy but without any allergic sensitisation and administer sub-lingually, a high daily dose of house-dust mite allergen extract for 12 months. Sub-lingual administration of allergen is considered safe, especially in these infants who are not sensitised. Assessment will be performed at 6, 12 and 18 months with validated questionnaires and skin prick tests, while a small blood sample will be collected at 6 and 18 months. Compliance to intervention and adverse effects will be noted at 12 and 18 months. Primary Outcome is cumulative sensitisation to house dust mite and any allergens from 6 to 18 months of age, while Secondary outcomes include allergic disease such as eczema at ages 12 and 18 month and alteration in immune responses at age 18 months. This 1 year double-blind, placebo-controlled study will provide early proof of efficacy in respect of atopy, with follow-up studies will demonstrate impact on asthma development.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/124

• Date of REC Opinion

  31 Dec 2009

• REC opinion

  Further Information Favourable Opinion