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)
This study has been completed.
Information provided by:
First received: September 8, 2005
Last updated: September 9, 2009
Last verified: September 2009
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Compare the effect of LCTZ and PLC on the time to onset of asthma after 18 months of treatment, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).
Secondary Outcome Measures:
- Compare the symptoms and medications used for asthma; investigate consistency of treatment effect found overall on the time to onset of asthma during treatment period; Assess safety of long-term use of LCTZ in a large population of children.
|Study Start Date:||March 2002|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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