Clinical trial NCT00152464: 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)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: EPAAC
Atopic children
Asthma
XYZAL
Levocetirizine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 514
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Onset of Asthma During the Treatment Period
timeFrame: During the treatment period (18 months)
Secondary outcomes:
measure: Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
timeFrame: During the treatment period (18 months)
measure: Percentage of Days With Symptoms of Wheezing
timeFrame: During the treatment period (18 months)
measure: Percentage of Days With Symptoms of Nocturnal Cough
timeFrame: During the treatment period (18 months)
measure: Percentage of Subjects Using Asthma Medication
timeFrame: During the treatment period (18 months)
measure: Percentage of Days of Use of Asthma Medication
timeFrame: During the treatment period (18 months)
measure: Percentage of Subjects Using Medication for Atopic Dermatitis
timeFrame: During the treatment period (18 months)
measure: Percentage of Days of Use of Medication for Atopic Dermatitis
timeFrame: During the treatment period (18 months)
measure: Percentage of Subjects With Urticaria
timeFrame: During the treatment period (18 months)
measure: Number of Episodes of Urticaria Per Subject
timeFrame: During the treatment period (18 months)
Other outcomes:
Locations:
Study officials:
References: