Table 6 Clinical studies of mometasone furoate

Meltzer EO, et al. 2000 [46]

Double-blind randomized trial

Patients with acute rhinosinusitis

n = 200 with MFNS 400 μg twice daily

n = 207 with placebo

Primary outcome:

From Day 1 to Day 15, mean TSS for patients receiving MFNS 400 μg twice daily decreased by 5.87 (50.5%), compared with a decrease of 5.05 (44.4%) in patients receiving placebo (p ≤ 0.01)

Secondary outcomes:

Individual symptom scores showed consistently greater improvement for patients treated with MFNS compared with placebo treatment, although relief of individual symptoms varied. Larger proportions of patients in the MFNS treatment group than in the placebo group showed improvements at Day 21

Nayak AS, et al. 2002 [47]

Double-blind randomized trial

Patients with acute rhinosinusitis

n = 325 with placebo

n = 318 with MFNS 200 μg twice daily

n = 324 with MFNS 400 μg twice daily

Primary outcome:

Treatment with MFNS 200 μg or 400 μg, twice daily, produced significantly greater improvements in total symptoms score from Day 1 to Day 15 than placebo (5.89, p = 0.014 and 5.86, p = 0.017 versus 5.22 with placebo)

Secondary outcomes:

Individual symptom scores showed consistently greater improvement for patients treated with either dose of MFNS compared with placebo. Both doses of MFNS were well tolerated. Cosyntropin stimulation showed no evidence of hypothalamic-pituitary-adrenal axis suppression.

Meltzer EO, et al. 2005 [48]

Double-blind randomized trial

Patients with acute rhinosinusitis

n = 243 with MFNS 200 μg once daily

n = 235 with MFNS 200 μg twice daily

n = 251 with amoxicillin three times daily

n = 252 with placebo

Primary outcome:

The difference in MSS from baseline with MFNS twice daily was significantly superior to placebo (p < 0.001) and amoxicillin (p = 0.002)

Secondary outcomes:

Global response to treatment was greater with MFNS twice daily than with amoxicillin (p = 0.013) and placebo (p = 0.001). All treatments had an acceptable tolerability profile

Bachert C, et al. 2007 [49]

Exploratory analysis of the double-blind randomized trial by Meltzer EO et al. 2005

Patients with acute rhinosinusitis

n = 243 with MFNS 200 μg once daily

n = 235 with MFNS 200 μg twice daily

n = 251 with amoxicillin three times daily

n = 252 with placebo

Main study outcomes:

There was a clinically meaningful (≥ 0.8) improvement (reduction) in LS mean total scores on the SNOT-20 questionnaire in all four treatment groups at Day 15, but the only significantly greater improvement was with MFNS twice daily versus placebo (p = 0.047)

Meltzer EO, et al. 2012 [50]

Post hoc analysis of the double-blind randomized trial by Meltzer EO et al. 2005

Patients with acute rhinosinusitis

n = 240 with MFNS 200 μg once daily

n = 233 with MFNS 200 μg twice daily

n = 248 with amoxicillin

n = 246 with placebo

Main study outcomes:

Patients receiving MFNS twice daily had more minimal-symptom day than patients treated with placebo (62.69% vs. 50.33%, p < 0.0001) or amoxicillin (62.69% vs. 54.35%, p = 0.0040).

Patients receiving MFNS once daily experienced a not significantly greater percentage of minimal-symptom days than those receiving placebo (54.72% vs. 50.33%, p = 0.1286) or amoxicillin (54.72% vs. 54.35%, p = 0.8982)

Zalmanovici Trestioreanu A, et al. 2013 [51]

Cochrane meta-analysis

Patients with acute rhinosinusitis

n = 1943 patients

Primary outcome:

MFNS 400 μg daily was superior to placebo for symptom resolution or improvement (RR 1.10; 95% CI 1.02 to 1.18, p = 0.0093) while MFNS 200 μg daily was similar to placebo (RR 1.04; 95% CI 0.98 to 1.11, p = 0.19)

Secondary outcome:

No significant adverse events were reported