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)

NCT ID: NCT00152464

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-20
• Study Completion Date: 2006-03-15

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 children.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Levocetirizine (LCTZ)

0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.

Group Type: EXPERIMENTAL

Levocetirizine

Intervention Type: DRUG

Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Placebo (PBO)

Placebo was administered as oral drops twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: Oral drops Route of administration: Oral use

Interventions

Placebo

Pharmaceutical form: Oral drops Route of administration: Oral use

Intervention Type: DRUG

Levocetirizine

Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Intervention Type: DRUG

Other Intervention Names

Xyzal

Eligibility Criteria

Inclusion Criteria

• 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)

• 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 Criteria

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

• Intake of any prohibited medication listed above during the selection period

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

A00309

Identifier Type: -

Identifier Source: org_study_id