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)

UCB

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Drug: Placebo; Drug: Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152464

A00309

Details and patient eligibility

About

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.

Enrollment: 514 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: No Healthy Volunteers

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 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 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups, including a placebo group

Levocetirizine (LCTZ)

Experimental group

Description:

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

Treatment:

Drug: Levocetirizine

Placebo (PBO)

Placebo Comparator group

Description:

Placebo was administered as oral drops twice daily.

Treatment:

Drug: Placebo