Background: Acute rhinosinusitis is a potentially serious inflammatory disease triggered by viral or, rarely, bacterial infections, causing symptoms for up to 4 weeks. We studied therapeutic effects of mometasone furoate nasal spray (MFNS) vs amoxicillin and placebo on increasing number of minimal symptom days.
Methods: Double-blind, parallel-group, placebo- and active-controlled 15-day study randomized subjects ≥12 old to MFNS 200 mcg QD, MFNS 200 mcg BID, amoxicillin 500 mg TID, or placebo. Subjects maintained daily symptom diaries. Qualified subjects had major rhinosinusitis symptom score (sum of rhinorrhea, postnasal drip, congestion, sinus headache, facial pain) ≥5 and ≤12 (maximum score, 15) for ≥7 but <28 days before baseline. There were no meaningful differences in baseline scores among the four groups. Minimal symptom day defined as average AM/PM major symptom score ≤4.
Results: Subjects treated with MFNS BID (n=234) experienced significantly more minimal symptom days than those receiving placebo (n=246) (63.2% vs 50.4%; P<0.001) or amoxicillin (n=248) (63.2% vs 53.6%; P=0.001). There was no significant difference between amoxicillin and placebo (P=0.278). Subjects’ and investigators’ evaluation of global response to treatment found that 75.7% subjects receiving MFNS achieved marked to complete relief vs 64.9% with amoxicillin (P≤0.009 vs MFNS) and 61.9% with placebo (P≤0.009 vs MFNS). Onset of action for MFNS BID was 1 day after first dose administered (Day 2). MFNS achieved statistical significance relative to amoxicillin on Day 4, maintained with clear distinction throughout study.
Conclusion: MFNS 200 mcg BID significantly increased number of minimal symptom days vs amoxicillin or placebo in subjects with acute rhinosinusitis.