CETIRIZINE IN CHILDREN WITH CHRONIC ALLERGIC RHINITIS - A MULTICENTER DOUBLE-BLIND-STUDY OF 2 DOSES OF CETIRIZINE AND PLACEBO

Cetirizine 2.5 mg or 5 mg twice daily was compared with Placebo over a 2-week period in a multicentre double-blind parallel group study in 138 (3 groups of 46) children aged 2 to 14 years with perennial allergic rhinitis. The principal symptoms of allergic rhinitis including nasal obstruction, nonpurulent rhinorrhoea, nasal pruritus, sneezing and pharyngeal drip were chosen for the evaluation of efficacy. In addition, sore throat, conjunctival erythema, lacrimation and ocular pruritus were also evaluated. Each symptom was assessed by investigators using a scale from 0 = 'none' to 4 = 'very severe' and requiring additional medication for control. Parents and patients were asked to record symptom severity on a scale of 0 (none) to 3 (severe) and any adverse events on a daily basis. Tolerability was assessed by means of reported adverse events, together with the results of routine clinical laboratory tests performed before and after treatment. Patients receiving cetirizine 10 mg daily had a significantly greater improvement in symptoms of perennial allergic rhinitis than patients on placebo as assessed by average symptom scores and investigators' global evaluation of efficacy. In addition, cetirizine 10 mg/day produced a significantly greater improvement in the symptoms of nasal obstruction and rhinorrhoea than either cetirizine 5 mg/day or placebo. Parents' evaluations also favoured cetirizine 10 mg/day ahead of both cetirizine 5 mg/day and placebo. Cetirizine was well tolerated. No patient withdrew from treatment because of an adverse event; furthermore, mild sedation was only occasionally reported.