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)

Last updated: August 13, 2018
Sponsor: UCB Pharma SA
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Asthma

Allergy

Treatment

N/A

Clinical Study ID

NCT00152464
A00309
  • Ages 12-24
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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 atleast 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-documentedhistory 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 dustmite (HDM) are available and Immunoglobulin E (IgE) level against GP >= 0.35 kUA/land/or IgE level against HDM ≥ 0.35 kUA/l

  • Safety laboratory results are within the normal range of the central laboratory orconsidered as not clinically significant or study disease related by the Investigator

Exclusion

Exclusion Criteria: 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 episodeconsisting of 3 (or more) consecutive nights resulting in sleep disturbances in aclinical setting where asthma is likely and other conditions have been excluded

  • Have chronic pulmonary diseases of any type, such as, but not limited to, cysticfibrosis, or any cranio-facial abnormality, e.g., cleft palate

  • Have a personal history of sleep apnea or who have siblings with a history of sleepapnea

  • 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 atopicdermatitis

  • 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) ofinhaled/intranasal corticosteroids: 1 month,

  • Ketotifen: 1 month,

  • Astemizole: 6 weeks

  • Have been treated with any antihistamine, including ketotifen, with daily intake formore 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

Study Design

Total Participants: 514
Study Start date:
March 20, 2002
Estimated Completion Date:
March 15, 2006