NCT00152464

Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)

The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Placebo	Pharmaceutical form: Oral drops Route of administration: Oral use
DRUG	Levocetirizine	Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Timeline

• Start date: 2002-03-20
• Primary completion: 2006-03-15
• Completion: 2006-03-15
• First posted: 2005-09-09
• Last updated: 2019-01-22
• Results posted: 2019-01-22