Conditions: Asthma
Keywords: Pediatry EPAAC atopic Children prevention of asthma Levocetirizine Xyzal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) arm 2: Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) arm 3: Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)

Interventions: intervention 1: LEVOCETIRIZINE intervention 2: Placebo
Intervention descriptions: intervention 1: 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months intervention 2: Oral drops, bid for 18 months

Protocol document: