Characterisation of patients receiving moxifloxacin for acute bacterial rhinosinusitis in clinical practice: results from an international, observational cohort study

Ralph Mösges, Martin Desrosiers, Pierre Arvis, Stephanie Heldner, Ralph Mösges, Martin Desrosiers, Pierre Arvis, Stephanie Heldner

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.

Conflict of interest statement

Competing Interests: Ralph Mösges has been a consultant for the following companies: AFI/Diamed, Alcon Pharma, ALK-Scherax, Allergen Therapeutics/Bencard, Allergopharma, Almirall, ASTA Medica/Meda, Sanofi/Aventis, Bayer, BGT Überlingen, Bitop AG, Daimler AG, Essex-Pharma, Ferrero, Fresenius, HAL, Hoechst AG, Intersan, Johnson & Johnson/Janssen Research, Karl Storz Tuttlingen, Klosterfrau Cologne, Lofarma, MSD, Novartis/Leti, Optima, Pfaff AG, Philips B.V., Pierre Fabre, Promonta, Roxall, Schering-Plough Kenilworth, Schwabe, Schwarz-Pharma, Servier/IRIS, Stada, Stallergénes Anthony, UCB, Ursapharm, Zyma. Ralph Mösges has received research grants from the following companies: AFI/Diamed, AIPrevent, Alcon Pharma, Almirall, ASTA Medica/Meda, Sanofi/Aventis, Bitop AG, Essex-Pharma, Grünenthal, HAL, Hoechst AG, Intersan, Johnson & Johnson/Janssen Research, Karl Storz Tuttlingen, Klosterfrau Cologne, Lofarma, Optima, Pierre Fabre, Promonta, Roxall, Schering-Plough Kenilworth, Servier/IRIS, Stallergénes Anthony, UCB, Ursapharm, Zyma. Ralph Mösges has received speaker’s honoraria: AFI/Diamed, AIPrevent, ALK-Scherax, Allergen Therapeutics/Bencard, Almirall, ASTA Medica/Meda, ASTRA AB, Asche, Sanofi/Aventis, Bayer, Bionorica, Dr. Beckmann, Essex-Pharma, Fresenius, GSK, Hoechst AG, Intersan, Johnson & Johnson/Janssen Research, MSD, Novartis/Leti, Pierre Fabre, Schering-Plough Kenilworth, Schwabe, Schwarz-Pharma, Servier/IRIS, Stada, Stallergénes Anthony, UCB, Yamanouchi. Pierre Arvis and Stephanie Heldner are paid employees of Bayer HealthCare (in France and Germany, respectively), the funder of this study. They are not stockholders in the company and they do not have patent applications. The Moxifloxacin used in this study is a Bayer product (Avelox®; approved for the studied indication). There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Figure 1. Flowchart of patient selection.
Figure 1. Flowchart of patient selection.
Figure 2. Recovery: Time to improvement of…
Figure 2. Recovery: Time to improvement of symptoms and time to symptom resolution.

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