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.

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: LEVOCETIRIZINE	Phase III

Further Study Details: 

Primary Outcomes: to compare the effect of LCTZ and PLC on the time to onset of asthma after 18 months of treatment, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).
Secondary Outcomes: • To compare the symptoms and the medications used for asthma during the treatment period.; • To investigate the consistency of the treatment effect found overall on the time to onset of asthma during the treatment period.; • To assess the safety of the long-term use of LCTZ in a large population of children.
Expected Total Enrollment:  2500

Ages Eligible for Study:  12 Months   -   24 Months,  Genders Eligible for Study:  Both

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 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.

Study chairs or principal investigators

Isabelle Campine, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  A00309
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152464
Health Authority: France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medicinal Devices; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Spain: Ministry of Health and Consumption; South Africa: Medicines Control Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Federal Ministry for Health and Women; Netherlands: Medicines Evaluation Board (MEB)
ClinicalTrials.gov processed this record on 2005-09-13