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Clinical Trial
. 1997 Jun;78(6):598-601.
doi: 10.1016/S1081-1206(10)63223-1.

Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children

Affiliations
Clinical Trial

Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children

I B Barlan et al. Ann Allergy Asthma Immunol. 1997 Jun.

Abstract

Background: The role of topical corticosteroids in the treatment of acute sinusitis has not been established in children.

Objective: An attempt was made to determine the impact of topical corticosteroids as an adjunct to antibiotic treatment in the management of childhood sinusitis.

Methods: In a double-blind, placebo-controlled study, 151 children with sinusitis were recruited from a general pediatric outpatient clinic and 89 completed a 3-week trial. Treatment consisted of amoxicillin-clavulanate potassium, 40 mg/kg/d tid, combined with bid nasal spray of either budesonide, 50 micrograms, to each nostril (n = 43) or placebo )n = 46_ for 3 weeks. Patients maintained daily symptom cards throughout the study and were examined by the same physician each week.

Results: Clinical symptoms and signs decreased significantly in both treatment groups in comparison to baseline (P < .01). We detected a significant improvement in the scores of the cough and nasal discharge at the end of second week in the budesonide group when compared with placebo (P < .05). Friedman nonparametric repeated measures ANOVA test revealed a significant decrease in the total weekly scores of cough during the second week of budesonide treatment (P < .001) in contrast to continuous decline during the second and third weeks in the placebo group (P < .001 and P < .05, respectively). While the nasal discharge score decreased significantly during the second week in the budesonide group (P < .01), no significant effect on the nasal discharge score was observed in the placebo group.

Conclusion: These data suggest that topical corticosteroids may be a useful ancillary treatment to antibiotics in childhood sinusitis and effective in reducing the cough and nasal discharge earlier in the course of acute sinusitis.

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