prevention of asthma with levocetirizine 18 month treatment in infants (12 - 24 months) suffering from eczema (atopic dermatitis) and sensitized to grass pollen and/or house dust mite (hdm)

Conditions: Dermatitis, Atopic

Summary: the early prevention of asthma in atopic children (epaac™). 24 months study to evaluate the efficacy and safety of levocetirizine (lctz) in preventing the onset of asthma in 12 to 24 months old children.


Eligibility criteria:
inclusion criteria: inclusion criteria which must be verified during screening visit (v1): * children of either sex aged between 12 and 24 months * subjects suffering from symptoms of atopic dermatitis (ad) lasting cumulatively for at least 2 months since birth * modified severity scoring of atopic dermatitis (scorad) index \>= 10 * subjects whose biological mother or father, or one sibling has a well-documented history of atopy (ad, allergic rhinitis or asthma) inclusion criteria which must be verified during randomization (v2): * results of the radio-allergosorbant (rast) test for grass pollen (gp) and house dust mite (hdm) are available and immunoglobulin e (ige) level against gp \>= 0.35 kua/l and/or ige level against hdm ≥ 0.35 kua/l * safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the investigator exclusion criteria: exclusion criteria to verify at screening visit (v1): are to be excluded from the participation in the study, those children who * have height or weight below the 5th percentile * have experienced at least one episode of wheezing when aged 6 months or over * have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded * have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate * have a personal history of sleep apnea or who have siblings with a history of sleep apnea * are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or fk 506 (tacrolimus) * have received or are receiving allergen - specific immunotherapy * suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis * have an insufficient wash-out period for the following medications: * intranasal or systemic antihistamines: 3 days, * intranasal or systemic decongestants: 3 days, * loratadine, desloratadine: 10 days, * chromones: 2 weeks, * oral corticosteroids: 1 month, * chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month, * ketotifen: 1 month, * astemizole: 6 weeks * have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening subject exclusion criteria to verify at randomization visit (v2): • intake of any prohibited medication listed above during the selection period

Keywords: epaac atopic children asthma xyzal levocetirizine