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)
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|ClinicalTrials.gov Identifier: NCT00152464|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : April 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: LEVOCETIRIZINE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2500 participants|
|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.|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152464
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|