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)
Condition: Dermatitis, Atopic
MeSH terms: Asthma; Dermatitis, Atopic; Dermatitis
Intervention: Placebo; Levocetirizine
Intervention description: Pharmaceutical form: Oral drops Route of administration: Oral use; Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
Intervention MeSH terms: Levocetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: No
Keywords: EPAAC; Atopic children; Asthma; XYZAL; Levocetirizine

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