Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)

Study Overview
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Brief Summary
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Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). 36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

Official Title
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The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.

Conditions
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Asthma

Intervention / Treatment
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* Drug: LEVOCETIRIZINE
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9) Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCTZ-LCTZ<br>Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) | Drug: LEVOCETIRIZINE<br>* 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months<br>* Other names: Xyzal®;|
| Placebo Comparator: LCTZ-PLC<br>Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) | Other: Placebo<br>* Oral drops, bid for 18 months<br>|
| Placebo Comparator: PLC-PLC<br>Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC) | Other: Placebo<br>* Oral drops, bid for 18 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of Asthma |  | 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. |  | 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal