Prevention of allergy development in preschool childre

Phase 1

• Conditions: Patients; children at age 4 years with house dust mite IgE sensitization without allergic disease; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-002844-18-AT
• Lead Sponsor: Medical University of Vienna, Dpt. of Pediatrics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-21
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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:
oIgE to food allergens without present food allergy, exposed to the particular food during the last 12 months,
omild eczema with effective treatment of group 1-2 steroids,
ovirus-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

•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:
osevere allergic rhino-conjunctivitis during pre-treatment season, need of systemic steroid,
obronchial asthma, with regular use of inhaled corticosteroids, long-activating bronchiodilators (LABA) and/or anti-leukotriene receptor agonists,
obefore or during treatment period - eczema, regular use of group 2 steroids >2 months the last 12 months,
osevere allergic disease and or severe other disease,
oother 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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: <br>a) at treatment start t0<br>b) one and 2 years after treatment start t12 and t24<br>c) 2 years after treatment stop t48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Efficacy: <br>a) development of new IgE-sensitizations<br>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: <br>a) at treatment start t0<br>b) one and 2 years after treatment start t12 and t24<br>c) 2 years after treatment stop t48