Objectives: This prospective, single-arm, open-label, multicentre phase IV (postmarketing surveillance) study determined time to resolution of key symptoms and return to normal activities in adults with acute bacterial maxillary sinusitis treated with moxifloxacin 400 mg qd for 10 days. The study also assessed whether responses to the Sino-Nasal Outcome Test-16 (SNOT-16) questionnaire [not yet validated for acute bacterial sinusitis (ABS)] accurately reflect clinical findings in these patients.
Methods: Adults with a clinical diagnosis of acute bacterial maxillary sinusitis with signs/symptoms present for > or = 7 but < 28 days took part. Patients were evaluated bacteriologically and clinically on day 1 (pretherapy), days 2-4 and 10-13 (test of cure), for bacterial presence and improvement/resolution of the signs/symptoms of acute bacterial maxillary sinusitis. They completed SNOT-16 and Activity Impairment Assessment questionnaires daily, before receiving moxifloxacin, until day 10.
Results: In both the bacteriologically and clinically evaluable populations, over 85% of patients showed clinical improvement by day 2, rising to over 96% by day 4. Pretherapy, according to the SNOT-16 questionnaire, almost all of the bacteriologically evaluable patients reported facial pain/pressure but this proportion had fallen to below 50% by day 4. In the bacteriologically evaluable population, 32/42 (76%) patients reported an improvement in facial pain/pressure from the pretherapy visit to day 4. Of patients showing improvement, 50% improved from 'moderate-to-severe facial pain' at pretherapy to 'no problem' at day 4. At day 4, 45-50% of patients reported impairment of normal activities, compared with 79-88% pretherapy.
Conclusions: Moxifloxacin rapidly improves the signs and symptoms of acute bacterial maxillary sinusitis and results in clinical cure in most patients. Responses to the SNOT-16 questionnaire accurately reflected clinical assessments, indicating that when fully validated the SNOT-16 questionnaire may be a valuable tool for the assessment of patient outcomes in ABS.