drugset / Trial / NCT00160563

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)

NCT00160563 ↗

Phase 3 Terminated 207 enrolled UCB Pharma
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2004-06
Primary completion
2006-03
Completion
2006-03

Outcome

Outcome not reported

Stopped: “The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Levocetirizine Unknown 0.125 mg/kg Oral
Subject Levocetirizine Unknown 5 mg/ml Oral

Indications