Objectives: To evaluate the efficacy and safety of moxifloxacin in the treatment of acute bacterial rhinosinusitis (ABRS).
Study design: Prospective, multicenter, randomized, double-blind, phase III trial.
Methods: Patients with ABRS defined by clinical, radiologic, and bacteriologic criteria were recruited to the study. Study treatments were 400 mg of oral moxifloxacin or a matching placebo daily for 5 days. The primary end point was clinical response at test-of-cure, 1 to 3 days after the end of therapy in the modified intent-to-treat (mITT) population (patients with positive culture for one of five prespecified pathogens). Secondary efficacy variables included patient-reported symptom improvement measured using the Sino-Nasal Outcome Test-16 (SNOT-16), and concomitant medication use.
Results: The mITT population consisted of 118 patients (moxifloxacin, n = 73; placebo, n = 45). Clinical success rates were numerically higher for moxifloxacin (78.1%, 57/73) versus placebo (66.7%, 30/45); (P = .189). Significantly greater mean reductions in SNOT-16 scores occurred in moxifloxacin- versus placebo-treated patients (-17.54 vs. -12.83; P = .032). Overall concomitant medication use was lower in moxifloxacin versus placebo patients (38.4%, 28/73 vs. 55.6%, 25/45 respectively). Premature discontinuation due to insufficient therapeutic effect was significantly lower in moxifloxacin- versus placebo-treated patients (8.2%, 6/73 vs. 22.2%, 10/45; P = .031). The rate of treatment-emergent adverse events in the ITT population was similar between arms (moxifloxacin 38.2%, 96/251; placebo 40.7%, 50/123).
Conclusions: Although moxifloxacin 5-day therapy for ABRS was not statistically superior to placebo for the primary end point, patients who received moxifloxacin had significantly greater improvements in health outcomes and used fewer concomitant medicines than patients treated with placebo, while experiencing no increase in adverse events.