36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
Official Title
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.
Conditions
Study Type
Interventional
Study Design
Randomized, Double-Blind, Placebo Control, Parallel Assignment
Further Details
Primary Outcome Measures:
Secondary Outcome Measures:
Study Start
June 2004
Eligibility & Criteria
Ages Eligible for Study: 30 Months – 42 Months
Genders Eligible for Study: Both
Inclusion Criteria:
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
Exclusion Criteria:
None
No longer recruiting
Total Enrolment
300
Contact Details
Parkville (North Melbourne), Australia
North Adelaide, Australia
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