Department of Otorhinolaryngology, Erasmus University Hospital Rotterdam, The Netherlands. fokkens@kno.fgg.eur.nl
Abstract
BACKGROUND: Budesonide aqueous nasal spray is a topical corticosteroid which at doses of 64 to 256 microg once daily has been found to be effective in the treatment of seasonal allergic rhinitis in adults and children.
OBJECTIVE: This study was conducted to determine the efficacy of budesonide aqueous nasal spray, 128 microg once daily, in children with perennial allergic rhinitis.
METHODS: This double-blind, randomized, placebo-controlled, parallel-group, multicenter study compared the efficacy and safety of budesonide aqueous nasal spray, 128 microg once daily intranasally, with placebo in 202 patients (aged 6 to 16 years) with perennial allergic rhinitis. Efficacy was evaluated daily by measurement of peak nasal inspiratory flow (PNIF), nasal symptom scores over 12 hours, and an overall evaluation of treatment efficacy. In a subset of patients (n = 76), quality of life was measured by validated questionnaires.
RESULTS: Budesonide, 128 microg once daily, was significantly more effective than placebo in improving the PNIF, combined and individual nasal symptom scores, and the overall evaluation of treatment efficacy. The onset of action was found to occur within the first 12-hour time interval evaluated for combined nasal symptoms and within 48 hours for PNIF. Budesonide was associated with reduced percentage of eosinophils in brush samples and reduced intake of rescue medication in comparison with placebo. Quality of life scores were reduced, but the differences did not reach significance.
CONCLUSIONS: Budesonide aqueous nasal spray, 128 microg once daily, is effective in children with perennial allergic rhinitis. Efficacy was demonstrated within 12 hours.