Abstract

The prevalence of seasonal allergic rhinitis among 1 to 12 year olds is between 10% and 20%. Cetirizine is a selective, once-daily H1 antagonist approved for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria in adults and children 2 years and older, and was recently approved for the treatment of perennial allergic rhinitis and chronic urticaria in children down to 6 months of age. This randomized, multicenter, double-blind, placebo-controlled study enrolled 172 children with seasonal allergic rhinitis, including a large subgroup with concomitant asthma. Cetirizine syrup or placebo were administered for 2 weeks. Cetirizine 10 mg once daily provided significant relief from symptoms of seasonal allergic rhinitis, both in children with and without concomitant asthma. Among subjects with asthma, the frequency and severity of asthma symptoms were similar between the cetirizine and placebo groups. Cetirizine caused no adverse effects on pulmonary function in subjects with concomitant asthma. This study builds on previously reported data describing the safety and efficacy of cetirizine in infants as young as 6 months, and indicates that cetirizine is safe, tolerable, and effective for controlling the symptoms of seasonal allergic rhinitis in children aged 6-11 years, including those with concomitant, intermittent asthma.

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