Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis

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Abstract
The present study compared the efficacy and safety of three dose levels of cetirizine (2.5, 5, and 10 mg) once a day with placebo over 14 days in 6-12-year-old children with perennial allergic rhinitis. The design was a double-blind, randomized, multicenter, parallel-group study. Five symptoms (sneezing, nasal discharge, nasal obstruction, nasal pruritus, and ocular pruritus) were rated according to severity by investigators at the visits and daily by patients. Eighty-three patients were randomized to placebo, 84 to 2.5 mg cetirizine, 85 to 5 mg cetirizine, and 76 to 10 mg cetirizine. Groups were comparable at inclusion. The primary efficacy variable was the percentage of days with no or only mild symptoms: at all doses, cetirizine appeared to be more effective than placebo, but a significant difference was reached only in the 10-mg group (difference in medians of 22%; P = 0.016). The test of linearity was significant (P = 0.026) for the percentage of asymptomatic days. The investigators' assessments at each visit scored the symptoms in the placebo group higher, i.e., more severe, than in the active groups, the 10-mg dose causing the greatest reduction in symptoms. Adverse events were infrequent and generally mild or moderate in severity. It was concluded that cetirizine at a 10-mg, once daily dose could be used to treat effectively 6-12-year-old children with perennial allergic rhinitis.

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