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.

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:

To assess the effect on the time to onset of asthma of 36-month treatment with Levocetirizine as compare to placebo, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).

Secondary Outcome Measures:

To investigate the clinical benefit on the time to onset of asthma after 36-month of treatment in the LCTZ-LCTZ group as compared to LCTZ-PLC group.

To investigate whether the benefit on the time to onset of asthma after 18-month of treatment with LCTZ can be maintained over an additional 18-month period, once active treatment is stopped

To investigate the clinical benefit on the time to onset of asthma of an additional 18-month treatment period in the subset of subjects still asthma-free after the first 18-month treatment period.

To assess the safety of the long-term use of LCTZ in a large population of children aged between 30 and 60 months.

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