Status:
COMPLETED
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)
Lead Sponsor:
UCB Pharma SA
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
12-24 years
Phase:
PHASE3
Brief 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 childr...
Eligibility Criteria
Inclusion
- Inclusion criteria which must be verified during screening visit (V1):
- Children of either sex aged between 12 and 24 months
- Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth
- Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index \>= 10
- Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)
- Inclusion criteria which must be verified during randomization (V2):
- Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (IgE) level against GP \>= 0.35 kUA/l and/or IgE level against HDM ≥ 0.35 kUA/l
- Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator
Exclusion
- Exclusion criteria to verify at screening visit (V1):
- Are to be excluded from the participation in the study, those children who
- Have height or weight below the 5th percentile
- Have experienced at least one episode of wheezing when aged 6 months or over
- Have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded
- Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate
- Have a personal history of sleep apnea or who have siblings with a history of sleep apnea
- Are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or FK 506 (Tacrolimus)
- Have received or are receiving allergen - specific immunotherapy
- Suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis
- Have an insufficient wash-out period for the following medications:
- Intranasal or systemic antihistamines: 3 days,
- Intranasal or systemic decongestants: 3 days,
- Loratadine, Desloratadine: 10 days,
- Chromones: 2 weeks,
- Oral corticosteroids: 1 month,
- Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month,
- Ketotifen: 1 month,
- Astemizole: 6 weeks
- Have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening
- Subject Exclusion criteria to verify at randomization visit (V2):
- • Intake of any prohibited medication listed above during the selection period
Key Trial Info
Start Date :
March 20 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2006
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT00152464
Start Date
March 20 2002
End Date
March 15 2006
Last Update
January 22 2019
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