A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECT OF INTRANASAL BUDESONIDE IN THE TREATMENT OF CHILDREN WITH SEASONAL RHINITIS

The effectiveness of the intranasal glucocorticosteroid budesonide was investigated in children with grass pollen-induced rhinitis during a pollen season. The trial was of a randomized, double-blind, placebo-controlled, parallel-group design with a one-week run-in period and a three-week treatment period. Twenty-four children received treatment with budesonide 200 mug bid and 27 children with placebo, administered by a nasal aerosol. Concomitant terfenadine, as required, was allowed in both groups. Recordings of nasal symptom severity, use of terfenadine and adverse effects were made in diaries. Nasal symptoms were significantly less severe in patients treated with budesonide as compared with placebo-treated patients. An overall assessment of treatment effect made by the children was significantly in favour of budesonide, and the consumption of terfenadine was significantly larger in the placebo than in the budesonide group. These results provide good evidence that intranasal budesonide is effective in seasonal rhinitis in children.