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      Daily home-based spirometry during withdrawal of inhaled corticosteroid in severe to very severe chronic obstructive pulmonary disease

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          Abstract

          The WISDOM study (NCT00975195) reported a change in lung function following withdrawal of fluticasone propionate in patients with severe to very severe COPD treated with tiotropium and salmeterol. However, little is known about the validity of home-based spirometry measurements of lung function in COPD. Therefore, as part of this study, following suitable training, patients recorded daily home-based spirometry measurements in addition to undergoing periodic in-clinic spirometric testing throughout the study duration. We subsequently determined the validity of home-based spirometry for detecting changes in lung function by comparing in-clinic and home-based forced expiratory volume in 1 second in patients who underwent stepwise fluticasone propionate withdrawal over 12 weeks versus patients remaining on fluticasone propionate for 52 weeks. Bland–Altman analysis of these data confirmed good agreement between in-clinic and home-based measurements, both across all visits and at the individual visits at study weeks 6, 12, 18, and 52. There was a measurable difference between the forced expiratory volume in 1 second values recorded at home and in the clinic (mean difference of −0.05 L), which may be due to suboptimal patient effort in performing unsupervised recordings. However, this difference remained consistent over time. Overall, these data demonstrate that home-based and in-clinic spirometric measurements were equally valid and reliable for assessing lung function in patients with COPD, and suggest that home-based spirometry may be a useful tool to facilitate analysis of changes in lung function on a day-to-day basis.

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          Most cited references 7

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          Statistical methods for assessing agreement between two methods of clinical measurement.

          In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old. Such investigations are often analysed inappropriately, notably by using correlation coefficients. The use of correlation is misleading. An alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability.
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            Bronchodilator reversibility in chronic obstructive pulmonary disease: use and limitations.

            The change in forced expiratory volume in 1 s (FEV1) after administration of a short-acting bronchodilator has been widely used to identify patients with chronic obstructive pulmonary disease (COPD) who have a potentially different disease course and response to treatment. Despite the apparent simplicity of the test, it is difficult to interpret or rely on. Test performance is affected by the day of testing, the severity of baseline lung-function impairment, and the number of drugs given to test. Recent data suggest that the response to bronchodilators is not enhanced in patients with COPD and does not predict clinical outcomes. In this Review we will discuss the insight that studies of bronchodilator reversibility have provided into the nature of the COPD, and how the abnormal physiology seen in patients with this disorder can be interpreted. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease.

              Combined treatment with inhaled corticosteroids and long acting beta2 agonists is approved for the treatment of chronic obstructive pulmonary disease (COPD), but little is known about the onset of effect of the combination. Data were used from 1465 patients with COPD entered into a large 1 year double blind trial with daily measurements of peak expiratory flow (PEF) and symptom scores. PEF was significantly higher after 1 day in patients treated with salmeterol 50 microg twice daily or the salmeterol/fluticasone propionate combination 50/500 microg twice daily than placebo. In patients treated with fluticasone propionate 500 microg twice daily alone, PEF differed from placebo after 2 days. The differences after 2 weeks compared with placebo were 16 l/min (95% confidence interval (CI) 11 to 21), 11 l/min (95% CI 6 to 16), and 27 l/min (95% CI 22 to 33) for salmeterol, fluticasone propionate, and the salmeterol/fluticasone propionate combination, respectively. For all treatments the effect on PEF after 2 weeks was comparable to that seen at the end of the study. The difference between the salmeterol/fluticasone propionate combination and placebo after 2 weeks as a percentage of baseline was similar for PEF and clinic forced expiratory volume in 1 second (FEV1). Differences in breathlessness scores were statistically significant after 1 day for the group treated with salmeterol alone and after 2 days for the combination group. The 2 week change in FEV1 was only partly indicative of a long term response in individual patients. The effects of salmeterol and fluticasone propionate, alone or in combination, on PEF and breathlessness are seen within days and most of the obtainable effect on these parameters is reached within 2 weeks.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2016
                22 August 2016
                : 11
                : 1973-1981
                Affiliations
                [1 ]Respiratory Institute, Servei de Pneumologia, Hospital Clínic IDIBAPS-CIBERES, Universitat de Barcelona, Barcelona, Spain
                [2 ]Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
                [3 ]Department of Sports Medicine, University of Tübingen, Tübingen, Germany
                [4 ]Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
                [5 ]Department of Respiratory Medicine, University Hospital Maastricht, Maastricht University, Maastricht, the Netherlands
                [6 ]Department of Biostatistics and Data Sciences, Boehringer Ingelheim, Bracknell, UK
                [7 ]Institute of Ageing and Chronic Disease, Aintree University Hospital, Liverpool, UK
                Author notes
                Correspondence: Roberto Rodriguez-Roisin, Respiratory Institute, Servei de Pneumologia, Hospital Clínic IDIBAPS-CIBERES, Universitat de Barcelona, Villarroel, 170, 08036 Barcelona, Spain, Tel +34 93 227 5404, Email rororo@ 123456clinic.ub.es
                Article
                copd-11-1973
                10.2147/COPD.S106142
                5001655
                © 2016 Rodriguez-Roisin et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                fev1, home-based spirometry, inhaled corticosteroid, lung function, severe copd

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