Development of atopy MedDRA version: 12.1 Level: LLT Classification code 10019857 Term: Hereditary allergy
Conditions
Interventions
Product Name: SIW08
Product Code: V01A
Pharmaceutical Form: Oromucosal drops
INN or Proposed INN: ATCcode V01AA03
CAS Number: N/A
Sponsors
Southampton University Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this research project is to provide evidence that by administering a common allergen such as house dust mite to children before they develop any sensitisation, we can induce tolerance to that allergen. This will prevent the immune system developing an allergic response and general sensitisation that ultimately leads to asthma and allergy development. The goal is to test the hypothesis that by intervening early in life we can alter the immune response and prevent asthma and allergy development. ;Secondary Objective: During the course of the study we will be collecting blood samples at 6 and 18 months. These samples will allow us to evaluate how the immune system responds to administeration of allergen, by analysing differences in active and placebo groups, in different types of immune cells, and chemicals that are released by these cells. Even if the intervention does not work, this analysis will still help us to determine why it did not work, what changes were introduced and what was lacking and how this can be improved for future trials.;Primary end point(s): The primary outcome measure for this study is the cumulative prevalence of sensitisation to house dust mite over the 12 months intervention period. | — |
Countries
United Kingdom
Outcome results
None listed