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 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 RAST test for GP and HDM are available and 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.
