Cetirizine for seasonal allergic rhinitis in children aged 2-6 years. A double-blind comparison with placebo.

A total of 107 children of both sexes between 2 and 6 years of age with pollen-induced seasonal allergic rhinitis (SAR) were entered in a multicentre study of double-blind parallel group design in which the effects of 5 mg cetirizine, given as drops from a solution containing 10 mg/ml once daily each evening for two weeks, were compared with those of identical placebo. Sneezing, rhinorrhea, nasal obstruction and nasal and ocular pruritus were the symptoms evaluated by means of symptom scores by investigators and, on daily record cards, by parents. Investigators also made a global evaluation at the end of treatment. Cetirizine was more active than placebo for each symptom evaluated both by parents and investigators. There were significant by more (p = 0.002) days during which symptoms were absent or mild, in the cetirizine than in the placebo group. When the maximum symptom scores rated by investigators at each visit were compared, the difference in favour of cetirizine at the end of treatment was statistically significant (p = 0.04). Global evaluation by investigators of changes in symptoms at the end of the study showed an improvement in both groups which was significantly greater with cetirizine, providing excellent or good improvement in 34/54 patients compared with 25/53 patients on placebo (p = 0.039). Tolerance was good. Three patients on cetirizine and none on placebo experienced mild somnolence.