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)

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.

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 Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Levocetirizine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: UCB Pharma SA

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2002
• Primary Completion (Actual): March 15, 2006
• Study Completion (Actual): March 15, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Levocetirizine; EPAAC; Atopic children; XYZAL
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Skin Diseases, Eczematous; Asthma; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Levocetirizine
• Other Study ID Numbers: A00309