Safety of nasal budesonide in the long-term treatment of children with perennial rhinitis

BACKGROUND: Intranasal budesonide is an efficacious treatment for perennial allergic rhinitis. Long-term effects on safety, particularly in children, need further investigation. OBJECTIVE: To investigate the long-term safety of intranasal budesonide in children. METHODS: In an open trial, 78 children (5-15 years) with perennial rhinitis were treated with intranasal budesonide pressurized metered dose inhaler 200 microg twice daily (delivered daily dose 256 microg) for 12 months; 43 children stayed in the study for 12 additional months and were switched to aqueous suspension (400 microg delivered daily dose) for 6 months. Statural growth, bone age, ophthalmologic and rhinoscopic status, cortisol and biochemical analyses in blood and urine were monitored during the first and second years, and adverse events (AEs) were continuously recorded. RESULTS: No significant effects on statural growth and bone age, compared with reference values, were observed. Morning plasma cortisol and 24-h urinary cortisol were not changed during treatment. Patients reported 195 AEs, most commonly nasal dryness (30%), blood-tinged secretions (21%) and, among non-nasal AEs, headache (13%). Rhinoscopy revealed no signs of mucosal atrophy, ulceration, or candidiasis but some nasal dryness. No treatment-related ophthalmological or biochemical aberrations were found. Reduction of blood eosinophils and nasal symptom scores, compared with pre-treatment values, indicated the efficacy of budesonide treatment. CONCLUSION: Long-term treatment for 1-2 years with intranasal budesonide 256-400 microg daily in children with perennial rhinitis revealed no negative effects on growth or endogenous cortisol production. Local side-effects were mild and patient symptoms decreased.