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
36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
The Prolongation of the EPAAC Trial (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.
Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary Outcome Measures:
Secondary Outcome Measures:
Eligibility & Criteria
Ages Eligible for Study: 30 Months – 42 Months
Genders Eligible for Study: Both
Inclusion criteria which must be verified at the end of first 18-months treatment (V9): Having completed the previous 18-month treatment period of the EPAAC trial
No longer recruiting
Parkville (North Melbourne), Australia
North Adelaide, Australia