NCT00152464CompletedPhase 3
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Pharma SA
- Enrollment
- 514
- Primary Endpoint
- Time to Onset of Asthma During the Treatment Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Levocetirizine (LCTZ)
Experimental
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Intervention: Levocetirizine (Drug)
Placebo (PBO)
Placebo Comparator
Placebo was administered as oral drops twice daily.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to Onset of Asthma During the Treatment Period
Time Frame: During the treatment period (18 months)
The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached.
Secondary Outcomes
- Percentage of Days With Symptoms of Nocturnal Cough(During the treatment period (18 months))
- Percentage of Subjects Using Asthma Medication(During the treatment period (18 months))
- Number of Episodes of Urticaria Per Subject(During the treatment period (18 months))
- Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough(During the treatment period (18 months))
- Percentage of Days of Use of Asthma Medication(During the treatment period (18 months))
- Percentage of Subjects Using Medication for Atopic Dermatitis(During the treatment period (18 months))
- Percentage of Days of Use of Medication for Atopic Dermatitis(During the treatment period (18 months))
- Percentage of Subjects With Urticaria(During the treatment period (18 months))
- Percentage of Days With Symptoms of Wheezing(During the treatment period (18 months))
Investigators
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