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

Ann Allergy Asthma Immunol. 1997 Jun;78(6):598-601. doi: 10.1016/S1081-1206(10)63223-1.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adolescent
  • Aerosols
  • Amoxicillin / therapeutic use*
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Inflammatory Agents / administration & dosage*
  • Budesonide
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Infant
  • Male
  • Penicillins / therapeutic use
  • Pregnenediones / administration & dosage*
  • Sinusitis / drug therapy*


  • Aerosols
  • Anti-Bacterial Agents
  • Anti-Inflammatory Agents
  • Penicillins
  • Pregnenediones
  • Budesonide
  • Amoxicillin