Added relief in the treatment of acute recurrent sinusitis with adjunctivemometasone furoate nasal spray

Background: Intranasal glucocorticoids are effective in the treatment of al lergic rhinitis, Their effectiveness as an anti-inflammatory adjunct in the treatment of acute recurrent sinusitis has not been adequately established in a controlled clinical study. Objective: The purpose of this study was to test the hypothesis that intran asal corticosteroid treatment produces additional relief in the treatment o f acute sinusitis with oral antibiotics. Methods: Patients who were 12 years old and older with a history of recurre nt sinusitis were treated while experiencing a new episode of acute sinusit is, which was diagnosed by symptoms and confirmed by computed tomography sc an of the paranasal sinuses. Patients were treated for 21 days with amoxici llin clavulanate potassium and randomized to receive concurrent mometasone furoate nasal spray (MFNS; Nasonex [400 mug, twice daily]; n = 200 patients ) or placebo spray (twice daily: n = 207 patients). Symptom scores for head ache, facial pain, congestion, purulent rhinorrhea, postnasal drip, and cou gh were recorded at baseline and throughout treatment. Results: Baseline sy mptom scores showed a moderate level of symptom severity comparable in both groups. Patient-recorded twice daily symptom scores showed that adjunctive treatment with MFNS caused a significantly greater decrease in total sympt om score (primary efficacy variable) and in individual scores of inflammato ry symptoms associated with the obstruction process (headache, congestion, and facial pain) compared with placebo. Symptoms associated with the secret ory processes were improved to a lesser degree. Therapy-related local adver se events were not significantly different between groups. Conclusion: The addition of intranasal corticosteroid, MFNS 400 mug twice d aily, to antibiotics significantly reduces symptoms of acute sinusitis comp ared with antibiotic treatment alone.