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      Changing patterns in long-acting bronchodilator trials in chronic obstructive pulmonary disease

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          Abstract

          Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Developments in the understanding of COPD have led to standard guidelines for diagnosis, treatment, and spirometry assessments, which have in turn influenced trial designs and inclusion criteria. Substantial clinical evidence has been gained from clinical trials and supports a positive approach to COPD management. However, there appear to be changing trends in recent trials. Large bronchodilator studies have reported lower improvements in trough forced expiratory volume in 1 second (FEV 1) values versus placebo than were observed in earlier studies, while the rate of FEV 1 decline seems to be lower in more recent trials. In addition, recent evidence has called into question the usefulness of bronchodilator reversibility testing as a trial inclusion criterion. Baseline patient populations and use of concomitant medications have also changed over recent years due to increased treatment options. The impact of these many variables on clinical trial results is explored, with a particular focus on changes in inclusion criteria and patient baseline demographics.

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          Most cited references 6

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          Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials

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            Lack of long-term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II.

            Inhaled corticosteroids (ICS) are widely used in the treatment of COPD. One of the potential adverse effects of their use is the development of adrenal suppression. Our study aimed to determine the effects of ICS on adrenal function over 3 years of use in patients with COPD.
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              Lung function decline in COPD trials: bias from regression to the mean

               S Suissa (2008)
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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
                07 January 2011
                : 6
                : 35-45
                Affiliations
                [1 ] Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
                [2 ] St. George’s, University of London, London, UK
                Author notes
                Correspondence: James F Donohue, Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA, Tel +1 919 966 2531, Fax +1 919 966 7013, Email jdonohue@ 123456med.unc.edu
                Article
                copd-6-035
                10.2147/COPD.S14680
                3034288
                21311692
                © 2011 Donohue and Jones, 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.

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