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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)

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Levocetirizine
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring EPAAC, Atopic children, Asthma, XYZAL, Levocetirizine

Eligibility Criteria

12 Months - 24 Months (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Levocetirizine (LCTZ)

    Placebo (PBO)

    Arm Description

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

    Placebo was administered as oral drops twice daily.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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
    Percentage of Subjects Using Asthma Medication
    The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
    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
    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
    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
    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.
    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.

    Full Information

    First Posted
    September 8, 2005
    Last Updated
    August 13, 2018
    Sponsor
    UCB Pharma SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00152464
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 20, 2002 (Actual)
    Primary Completion Date
    March 15, 2006 (Actual)
    Study Completion Date
    March 15, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Pharma SA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatitis, Atopic
    Keywords
    EPAAC, Atopic children, Asthma, XYZAL, Levocetirizine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    514 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levocetirizine (LCTZ)
    Arm Type
    Experimental
    Arm Description
    0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
    Arm Title
    Placebo (PBO)
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo was administered as oral drops twice daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Pharmaceutical form: Oral drops Route of administration: Oral use
    Intervention Type
    Drug
    Intervention Name(s)
    Levocetirizine
    Other Intervention Name(s)
    Xyzal
    Intervention Description
    Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
    Primary Outcome Measure Information:
    Title
    Time to Onset of Asthma During the Treatment Period
    Description
    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.
    Time Frame
    During the treatment period (18 months)
    Secondary Outcome Measure Information:
    Title
    Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
    Description
    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.
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Days With Symptoms of Wheezing
    Description
    The caring person was to note on the diary card each each wheezing event occurring at any time.
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Days With Symptoms of Nocturnal Cough
    Description
    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
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Subjects Using Asthma Medication
    Description
    The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Days of Use of Asthma Medication
    Description
    The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Subjects Using Medication for Atopic Dermatitis
    Description
    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
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Days of Use of Medication for Atopic Dermatitis
    Description
    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
    Time Frame
    During the treatment period (18 months)
    Title
    Percentage of Subjects With Urticaria
    Description
    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.
    Time Frame
    During the treatment period (18 months)
    Title
    Number of Episodes of Urticaria Per Subject
    Description
    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.
    Time Frame
    During the treatment period (18 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
    Description
    FDA Safety Alerts and Recalls

    Learn more about this trial

    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)

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