OBJECTIVE: While it is widely accepted that inhaled glucocorticosteroids represent an effective treatment for allergic rhinitis, little is known on the specific effects of this therapeutic approach in other upper airway disorders of childhood. The aim of the study was to evaluate the improvement of clinical symptoms and changes in local cellular inflammatory reaction induced by budesonide inhalation suspension in children with recurrent nasal infections using budesonide inhalation suspension delivered by Rinowash, a nebulizer designed to treat upper airway structures. METHODS: In a randomized, controlled-open study, 14 children (5.88+/-0.56 years of age) with recurrent upper airway infections and chronic nasal obstruction were enrolled and randomly treated for 7-10 days either with budesonide inhalation suspension (250 microg/bidie) (nine patients) or with saline solution (five patients). Before and after treatment, inflammatory cells in nasal brushing and nasal symptom score were evaluated. RESULTS: Out of the nine patients treated with budesonide, two were excluded from the analysis because of acute respiratory infections requiring systemic antibiotic treatment. A significant decrease in nasal brushing neutrophil percentage was observed after treatment with budesonide (P=0.016) but not after saline solution treatment (P=1.00). No significant changes in nasal brushing mononuclear cell or eosinophil proportions were observed after treatment with budesonide inhalation suspension or saline solution (P=NS, each comparison). Treatment with budesonide, but not with saline solution, was associated with a significant reduction in nasal obstruction (P=0.016). CONCLUSIONS: These preliminary data indicate that short-term treatment with budesonide inhalation suspension, used for an indication out of label, may significantly reduce local neutrophilic inflammation and nasal obstruction in children with recurrent upper airway infections.
RCT Entities:
OBJECTIVE: While it is widely accepted that inhaled glucocorticosteroids represent an effective treatment for allergic rhinitis, little is known on the specific effects of this therapeutic approach in other upper airway disorders of childhood. The aim of the study was to evaluate the improvement of clinical symptoms and changes in local cellular inflammatory reaction induced by budesonide inhalation suspension in children with recurrent nasal infections using budesonide inhalation suspension delivered by Rinowash, a nebulizer designed to treat upper airway structures. METHODS: In a randomized, controlled-open study, 14 children (5.88+/-0.56 years of age) with recurrent upper airway infections and chronic nasal obstruction were enrolled and randomly treated for 7-10 days either with budesonide inhalation suspension (250 microg/bidie) (nine patients) or with saline solution (five patients). Before and after treatment, inflammatory cells in nasal brushing and nasal symptom score were evaluated. RESULTS: Out of the nine patients treated with budesonide, two were excluded from the analysis because of acute respiratory infections requiring systemic antibiotic treatment. A significant decrease in nasal brushing neutrophil percentage was observed after treatment with budesonide (P=0.016) but not after saline solution treatment (P=1.00). No significant changes in nasal brushing mononuclear cell or eosinophil proportions were observed after treatment with budesonide inhalation suspension or saline solution (P=NS, each comparison). Treatment with budesonide, but not with saline solution, was associated with a significant reduction in nasal obstruction (P=0.016). CONCLUSIONS: These preliminary data indicate that short-term treatment with budesonide inhalation suspension, used for an indication out of label, may significantly reduce local neutrophilic inflammation and nasal obstruction in children with recurrent upper airway infections.
Authors: Gail Hayward; Matthew J Thompson; Rafael Perera; Chris B Del Mar; Paul P Glasziou; Carl J Heneghan Journal: Cochrane Database Syst Rev Date: 2015-10-13