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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00152464 |
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.
Condition | Intervention | Phase |
---|---|---|
Dermatitis, Atopic |
Drug: LEVOCETIRIZINE |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, 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. |
Estimated Enrollment: | 2500 |
Study Start Date: | March 2002 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Months to 24 Months |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Inclusion criteria which must be verified during screening visit (V1):
Inclusion criteria which must be verified during randomization (V2):
Exclusion Criteria:
Are to be excluded from the participation in the study, those children who
Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids:
1 month,
Subject Exclusion criteria to verify at randomization visit (V2):
Study ID Numbers: | A00309 |
Study First Received: | September 8, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00152464 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Spain: Ministry of Health and Consumption; South Africa: Medicines Control Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Federal Ministry for Health and Women; Netherlands: Medicines Evaluation Board (MEB) |
EPAAC , atopic Children, asthma, XYZAL, levocetirizine |
Neurotransmitter Agents Dermatitis, Atopic Skin Diseases Asthma Anti-Allergic Agents Eczema Cetirizine Histamine Hypersensitivity |
Histamine Antagonists Genetic Diseases, Inborn Levocetirizine Hypersensitivity, Immediate Histamine phosphate Skin Diseases, Eczematous Histamine H1 Antagonists Skin Diseases, Genetic Dermatitis |
Neurotransmitter Agents Dermatitis, Atopic Molecular Mechanisms of Pharmacological Action Skin Diseases Immune System Diseases Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents Cetirizine Pharmacologic Actions Hypersensitivity |
Histamine Antagonists Genetic Diseases, Inborn Levocetirizine Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Skin Diseases, Genetic Dermatitis |