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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
514
Pharmaceutical form: Oral drops Route of administration: Oral use
Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
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.
Time frame: During the treatment period (18 months)
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: During the treatment period (18 months)