Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). 36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
Oral drops, bid for 18 months
Time to Onset of Asthma
Time frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
Time frame: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
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North Adelaide, Australia
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Parkville (North Melbourne), Australia
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Brussels, Belgium
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Plezen-Lochotin, Czechia
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Prague, Czechia
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Martigues, France
...and 41 more locations