- 151 patients diagnosed with acute sinusitis were initially enrolled.1
Sinusitis was defined as 2 of 3 major criteria (purulent nasal discharge,
pharyngeal drainage, cough) or 1 major and 2 minor criteria (periorbital
edema, facial pain, tooth pain, earache, increased wheeze, foul breath,
fever). These symptoms needed to be present for at least 7 days.2
- Water's view X-rays were positive (>4 mm membrane thickening)
in 79 of 89 patients.
- Patients were excluded if they had a history of allergic rhinitis,
asthma, or chronic sinusitis.
- The patients were randomized to Augmentin (40 mg/kg/day) plus budesonide
(N=43) or placebo (N=46) nasal sprays for a three week treatment course.
Patients and evaluators were blinded to which nasal spray each patient
was using. There were no significant differences between the groups.
- The patients or their parents kept a daily symptom log for nasal
discharge and cough. They rated their symptoms on a scale of 0-3 (0=no
symptom, 3=severe symptom). The patients also were seen by the same
physician for weekly follow up.
- 62 patients did not follow through with the daily logs and were dropped
from the study. One child was changed to cefaclor due to development
of a rash with Augmentin.
- Daily symptom scores were totaled each week and the groups were compared
by median weekly symptom score using ANOVA.
- The budesonide group had a significantly greater decrease in both
cough and nasal discharge at 2 weeks over the control group.
- Both groups had significant improvement in their symptoms after three
weeks treatment. There was no significant difference between the symptom
scores of the two groups at the end of the trial.
- Two patients from each group had relapse of sinusitis within one
month after completion of the study.