Children (2-4years of age) from atopy prone families with an allergic sensitization as defined by positive skin prick test or positive allergen-specific IgE to grass pollen or house dust mite allergen without presence of manifest allergic disease
Conditions
Interventions
Trade Name: Novo Helisen oral Pollen
Pharmaceutical Form: Oral drops*
Pharmaceutical form of the placebo: Oral drops*
Route of administration of the placebo: Sublingual use
Trade Name: Novo Helisen o
Sponsors
Medizinische Universität Wien, Univ. Kinderklinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - children of age 2-4 years (>24 month of age) - positive family history for allergic diseases - presence of positive skin prock test reactivity and/or allergen-specific IgE-antibodies to either house dust mite allergen or grass pollen allergen - optionally symptoms indicative of asthma/wheezing bronchitis and rhinitis without persistent treatment need in the last 6 months - optionally atopic dermatitis in the subjects own history 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: - children younger than 24 months or older than 5 years of age - symptoms indicative of asthma/wheezing bronchitis or rhinitis with continuous medical treatment with controller medication in the last 6 months - use of specific immunotherapy in the past or currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The pupose of the trial is to test whether sublingual immunotherapy applied in children with monosensitization to either house dust mite or grass pollen allergens can prevent the development of new sensitizations in the following 2 years (secondary prevention);Secondary Objective: ;Primary end point(s): primary end point of the study is the assessment of new sensitizations in skin prick test or allergen-specific IgE-antibody detection during the 2 year sublingual treatment period | — |
Countries
Austria
Outcome results
None listed