INTRANASAL FLUNISOLIDE SPRAY AS AN ADJUNCT TO ORAL ANTIBIOTIC-THERAPYFOR SINUSITIS

Background: The diagnosis of sinusitis is difficult and there are few controlled studies Of customary therapies. In particular, the possible role of topical intranasal steroid as an adjunct to antibiotic treatm ent has not been evaluated Methods: The study was a multicenter, doubl e-blind, randomized, parallel trial in which patients aged 14 years or older were recruited from allergy practices. All patients had maxilla ry sinusitis documented by radiographs. Treatment consisted of amoxici llin/clavulanate postassium 500 mg combined with nasal spray of either 100 mug fl or placebo 10 each nostril three times a day for 3 weeks ( phase I) followed by administration of flunisolide or placebo nasal sp ray alone three times a day for 4 weeks (phase II). Results: Clinical symptoms and signs decreased significantly in both treatment groups du ring phase I (p < 0.01). There was a trend to greater improvement in t he patients treated with flunisolide, but only the decrease in turbina te swelling/obstruction was statistically significant at the end of ph ase I when compared with placebo (p = 0.041). Patients' global assessm ent of overall effectiveness of treatment was higher for flunisolide t han placebo after phase I (p = 0.007) and after phase II (p = 0.08). M axillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnorm al findings in patients treated with flunisolide after phase II (p = 0 .066). However, 80% of radiographs were still abnormal at the end of p hase L All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison wi th those treated with placebo. Flare-up of sinusitis during phase II o ccurred in 26% of patients treated with flunisolide and 35% of those t reated with placebo and tended to be more severe in the latter, althou gh these differences were not statistically significant. Adverse event s, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patie nts); these side effects were probably due to the antibiotic. Conclusi on: The addition of flunisolide topical nasal spray as an adjunct to a ntibiotic was most effective in global evaluations, tended to improve symptoms, to decrease inflammatory cells in nasal cytograms, to normal ize ultrasound scans, and to aid regression of abnormalities compared with placebo spray.