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Once-Daily Cetirizine Effective in the Treatment of Seasonal Allergic Rhinitis in Children Aged 6 to 1 Years: A Randomized, Double-Blind, Placebo-Controlled Study

Department of Pediatrics, University of Colorado School of Medicine, Medical College-Ohio; Colorado Allergy and Asthma Clinic, 1450 South Havana Street, Aurora, CO 80012

William R. Lumry, MD

Department of Internal Medicine, University of Texas Health Science Center-Dallas, Southwestern Medical School, Medical College-Ohio

John A. Winder, MD

Department of Family Medicine and Pediatrics, Medical College-Ohio

Michael J. Noonan, MD

Department of Medicine, University of Oregon Health Center

Cetirizine (once daily), a highly selective HI-antagonist, is efficacious for treating seasonal allergic rhinitis (SAR), perennial allergic rhinitis, and chronic idiopathic urticaria. A 4-week, randomized, double-blind, placebo-controlled trial investigated the safety and efficacy of cetirizine syrup (5 or 10 mg daily) in 209 children ages 6 to 11 years with SAR. Parents assisted patients in recording symptom severity (sneezing, nasal discharge, itchy eyes, itchy nose or mouth, conjunctivitis, nasal congestion) daily. A total symptom severity (TSS) score was derived from all symptoms, excluding nasal congestion. At baseline, TSS was comparable for all groups (range 6.8-7.0). Cetirizine 10 mg produced a significantly greater mean TSS reduction (3.2) than placebo (P<0.05) over the treatment period. Cetirizine 5 mg once daily produced mean reductions in weekly symptom scores of 2.4; this did not differ statistically from placebo. Furthermore, cetirizine 10 mg significantly improved symptoms of itchy eyes, nose, or mouth. The most commonly reported adverse reactions to both cetirizine and placebo were headache, pharyngitis, and abdominal pain, which did not occur with an incidence statistically different from that of placebo. Once-daily cetirizine is safe for treating SAR in children ages 6-11 years. Once-daily cetirizine 10 mg provides effective improvement in symptoms and is well tolerated.

Clinical Pediatrics, Vol. 36, No. 4, 209-215 (1997)
DOI: 10.1177/000992289703600405


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