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)

Study Overview
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Brief Summary
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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.

Official Title
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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
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Placebo
* Drug: Levocetirizine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levocetirizine (LCTZ)<br>0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. | Drug: Levocetirizine<br>* Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use<br>* Other names: Xyzal;|
| Placebo Comparator: Placebo (PBO)<br>Placebo was administered as oral drops twice daily. | Drug: Placebo<br>* Pharmaceutical form: Oral drops Route of administration: Oral use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of Asthma During the Treatment Period | 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. | During the treatment period (18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms. | During the treatment period (18 months) | 
| Percentage of Days With Symptoms of Wheezing | The caring person was to note on the diary card each each wheezing event occurring at any time. | During the treatment period (18 months) | 
| Percentage of Days With Symptoms of Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am | During the treatment period (18 months) | 
| Percentage of Subjects Using Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | During the treatment period (18 months) | 
| Percentage of Days of Use of Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | During the treatment period (18 months) | 
| Percentage of Subjects Using Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics | During the treatment period (18 months) | 
| Percentage of Days of Use of Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics | During the treatment period (18 months) | 
| Percentage of Subjects With Urticaria | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | During the treatment period (18 months) | 
| Number of Episodes of Urticaria Per Subject | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | During the treatment period (18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPAAC, Atopic children, Asthma, XYZAL, Levocetirizine