Patients
Conditions
Interventions
Trade Name: Staloral - house dust mite
Product Name: Staloral house dust mite
Product Code: ALL-0012 A66 ALL-0012 A67
Pharmaceutical Form: Sublingual spray, solution
INN or Proposed INN: allergen ext
Sponsors
Medical University of Vienna, Dpt. of Pediatrics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children four years of age with sensitization to house dust mite without clinical history of allergic symptoms are eligible for study participation: • age of 4 years • house dust mite sensitization (SPT > 3mm or specific IgE > 0.35 kU/l) • additional sensitization to no maximum 3 inhalant or nutritive allergens in total (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk) • no allergic symptoms from the upper airways and/or eyes during house dust mite exposure (validated by allergen provocation chamber exposure) • other accepted atopic manifestations of the index child are: o IgE to food allergens without present food allergy, exposed to the particular food during the last 12 months, o mild eczema with effective treatment of group 1-2 steroids, o virus-induced asthma/preschool wheeze up to the last 12 months, Are the trial subjects under 18? yes Number of subjects for this age range: 96 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: • Perennial upper airway symptoms (rhinorrhea, congestion), • poly-sensitization to airborne and nutritive allergens, = 4 different inhalant allergens (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk), • clinical food allergy with IgE-sensitization, • at randomisation: o severe allergic rhino-conjunctivitis during pre-treatment season, need of systemic steroid, o bronchial asthma, with regular use of inhaled corticosteroids, long-activating bronchiodilators (LABA) and/or anti-leukotriene receptor agonists, o before or during treatment period - eczema, regular use of group 2 steroids >2 months the last 12 months, o severe allergic disease and or severe other disease, o other immune disease or children on immune regulating medication. • pregnancy or lactation • significant medical conditions, e.g. concomitant liver-, gastrointestinal-, kidney-, cardiovascular-, or pulmonary conditions, auto-immune diseases, hematological disorders or malignant diseases • a history of monoclonal antibody therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To induce protective immunomodulation (increase of allergen-specific IgG, IgG4, TGFb, IL10) in children with IgE-sensitization to house dust mite without allergic disease manifestation at the age of 4 years ;Secondary Objective: a) to prevent the development of new IgE-sensitizations b) to prevent the development of clinical symptoms of allergy ;Primary end point(s): Primary efficacy: Induction of immunomodulatory effects (allergen-specific IgG and IgG4 and TGFb and IL10) by house dust mite specific immunotherapy in 4 year old children with house dust mite IgE sensitisation without allergic disease;Timepoint(s) of evaluation of this end point: Evaluation of the primary end point parameter will be assessed: a) at treatment start t0 b) one and 2 years after treatment start t12 and t24 c) 2 years after treatment stop t48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy: a) development of new IgE-sensitizations b) development of clinical symptoms of allergy ;Timepoint(s) of evaluation of this end point: Evaluation of the secondary end point parameter will be assessed: a) at treatment start t0 b) one and 2 years after treatment start t12 and t24 c) 2 years after treatment stop t48 | — |
Countries
Austria
Contacts
Public ContactZsolt Szepfalusi, PI
Dpt. of Pediatrics, Div. of Ped Pneumology, Allergy and Endocrinology, Medical University of Vienna
Outcome results
None listed