- ICH GCP
- US Clinical Trials Registry
- 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)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
Other Names:
|
Placebo Comparator: Placebo (PBO)
Placebo was administered as oral drops twice daily.
|
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
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. |
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Time Frame: During the treatment period (18 months)
|
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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