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)

The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.

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.

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