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      A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology

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          Abstract

          Antibiotics, along with oral corticosteroids, are standard treatments for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The ultimate aims of treatment are to minimize the impact of the current exacerbation, and by ensuring complete resolution, reduce the risk of relapse. In the absence of superiority studies of antibiotics in AECOPD, evidence of the relative efficacy of different drugs is lacking, and so it is difficult for physicians to select the most effective antibiotic. This paper describes the protocol and rationale for MAESTRAL ( moxifloxacin in AECB s [acute exacerbation of chronic bronchitis] tri al; www.clinicaltrials.gov: NCT00656747), one of the first antibiotic comparator trials designed to show superiority of one antibiotic over another in AECOPD. It is a prospective, multinational, multicenter, randomized, double-blind controlled study of moxifloxacin (400 mg PO [ per os] once daily for 5 days) vs amoxicillin/clavulanic acid (875/125 mg PO twice daily for 7 days) in outpatients with COPD and chronic bronchitis suffering from an exacerbation. MAESTRAL uses an innovative primary endpoint of clinical failure: the requirement for additional or alternate treatment for the exacerbation at 8 weeks after the end of antibiotic therapy, powered for superiority. Patients enrolled are those at high-risk of treatment failure, and all are experiencing an Anthonisen type I exacerbation. Patients are stratified according to oral corticosteroid use to control their effect across antibiotic treatment arms. Secondary endpoints include quality of life, symptom assessments and health care resource use.

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          Most cited references 16

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          Chronic obstructive pulmonary disease, risk factors, and outcome trials: comparisons with cardiovascular disease.

          Chronic obstructive pulmonary disease (COPD) is a major health problem and now ranks fifth in terms of the global burden of disease. Although COPD is a disease that is characterized by progressive respiratory symptoms and functional decline, exacerbations pose the greatest risk for morbidity and early mortality, have a dramatic effect on quality of life, and are the most significant source of health care expenditure. To improve survival and reduce costs, it is critical to develop effective programs designed to reduce the frequency and severity of exacerbations for these patients. With limited health care resources, efficient and effective management of COPD ideally involves identifying and focusing efforts on individuals at particular risk. In the development of an appropriate multimodal strategy, lessons could be learned from the evolution of guidelines and management of cardiovascular disease, in particular heart failure, which has many parallels with COPD in terms of prevalence, prognosis, and impact on patient quality of life. There is a need for large prospective trials in COPD, based on hard clinical outcomes such as death, which, together with physician and patient education, will help to drive improvements in clinical management.
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            The infection-free interval: its use in evaluating antimicrobial treatment of acute exacerbation of chronic bronchitis.

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              Role of infection and antimicrobial therapy in acute exacerbations of chronic obstructive pulmonary disease.

              Over the past several years, the significance of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in patients with chronic airflow obstruction has become increasingly apparent due to the impact these episodes have on the natural history of disease. It is now known that frequent AECOPD can adversely affect a patient's health-related quality of life and short- and long-term pulmonary function. The economic burden of these episodes is also substantial. AECOPDs represent a local and systemic inflammatory response to both infectious and noninfectious stimuli, but the majority of episodes are likely related to bacterial or viral pathogens. Patients with purulent sputum and multiple symptoms are the most likely to benefit from treatment with antibiotics. Antibiotic choice should be tailored to the individual patient, taking into account the severity of the episode and host factors which might increase the likelihood of treatment failure. Current evidence suggests that therapeutic goals not only include resolution of the acute episode, but also prolonging the time to the next event. In the future, preventing exacerbations will likely become increasingly accepted as an additional therapeutic goal in chronic obstructive pulmonary disease patients.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2011
                2011
                29 June 2011
                : 6
                : 373-383
                Affiliations
                [1 ] Host Defence Unit, Royal Brompton Hospital, London, England, UK
                [2 ] University of Texas Health Science Center at San Antonio, South Texas Veterans HealthCare System, San Antonio, TX, USA
                [3 ] Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Ciber de Enfermedades Respiratorias (CIBERES), Hospital Clinic, Barcelona, Spain
                [4 ] Bayer HealthCare, Loos, France
                [5 ] Bayer Inc, Toronto, ON, Canada
                [6 ] Bayer HealthCare Pharmaceuticals, Montville, NJ, USA
                [7 ] Division of Pulmonary, Critical Care and Sleep Medicine, University at Buffalo, State University of New York, Buffalo, NY, USA
                Author notes
                Correspondence: Robert Wilson, Host Defence Unit, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK, Tel +44 207 351 8337, Fax +44 207 351 8338, Email r.wilson@ 123456rbht.nhs.uk
                Article
                copd-6-373
                10.2147/COPD.S21071
                3133509
                21760724
                © 2011 Wilson et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Methodology

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