Characterisation of Patients Receiving Moxifloxacin for Acute Bacterial Rhinosinusitis in Clinical Practice: Results from an International, Observational Cohort Study

Abstract

We conducted a prospective, non-controlled, multi-centre Phase IV observational cohort study of patients with acute bacterial rhinosinusitis who were treated with moxifloxacin in clinical practice in 19 countries in Asia Pacific, Europe and the Middle East. With the data collected we evaluated the presentation and course of the current disease episode, particularly in terms of the principal clinical signs and symptoms of acute rhinosinusitis and diagnostic procedures. A final assessment of moxifloxacin therapy was made to evaluate the impact of the sinusitis episode on activities of daily life and on sleep disturbance, and to evaluate the clinical outcome of treatment. A total of 7,090 patients were enrolled, of whom 3909 (57.6%) were included in the valid for clinical outcome and safety population. Regional differences were observed in the main symptoms of acute rhinosinusitis and, according to several characteristics, disease episodes appeared to be more severe in patients in Europe than in the Asia Pacific or Middle East regions. The sinusitis episode impacted on daily living for mean (SD) periods of 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) days and disturbed sleep for 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) nights in the Asia Pacific, Europe and Middle East regions, respectively. With moxifloxacin treatment, the mean (SD) time to improvement of symptoms was 3.0 (1.5), 3.4 (1.6) and 3.2 (1.5) days, and the time to resolution of symptoms was 4.8 (2.6) days, 5.7 (2.4) days and 5.5 (2.5) days, in the Asia Pacific, Europe and Middle East regions, respectively. In conclusion, acute rhinosinusitis remains a substantial health burden with significant impact on patients’ quality of life, and there are differences between global regions in the clinical presentation, diagnosis and clinical course of disease episodes. Moxifloxacin was an effective and well-tolerated treatment option in the overall population. Registration: ClinicalTrials.gov Identifier: NCT00930488

Adjunctive moxifloxacin in the treatment of generalized aggressive periodontitis patients: clinical and microbiological results of a randomized, triple‐blind and placebo‐controlled clinical trial

“…They included 150 subjects less than 20 years and the most frequently reported adverse events were nausea, followed by diarrhoea (Mösges et al. ).…”

15-year experience of moxifloxacin in the treatment of patients with bacterial rhinosinusitis

“…Подвести итог анализу литературных данных в отношении эффективности и безопасности моксифлоксацина можно международным наблюдательным исследованием R. Mosges и соавт. [33], включающем анализ данных 7090 пациентов с ОБР, получавших терапию авелоксом в клинической практике в странах Средней Азии, Европы и Юго-Восточной Азии, в результате которого было отмечено, что клиническое улучшение при терапии моксифлоксацином наступало в среднем через 3,2±1,5 дня, а полное отсутствие симптомов отмечалось через 5,3±2,6 дня. При этом различия в эффективности и безопасности моксифлоксацина в зависимости от географического региона не были установлены.…”