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      Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial

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          Abstract

          Background

          Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with loss of lung function and poor outcomes for patients. However, there are limited data on the time course of changes in forced expiratory volume in 1 s (FEV 1) preceding the first reported symptom and after the start of an exacerbation.

          Methods

          WISDOM was a multinational, randomized, double-blind, active-controlled, 52-week study in patients with severe-to-very severe COPD. Patients received triple therapy (long-acting muscarinic antagonist and long-acting β 2-agonist/inhaled corticosteroid [ICS]) for 6 weeks, and were randomized to continue triple therapy or stepwise withdrawal of the ICS (dual bronchodilator group). After suitable training, patients performed daily spirometry at home using a portable, battery-operated spirometer. In the present post hoc analysis, patients who continued to perform daily home spirometry and completed at least one measurement per week for a 56-day period before and after the start of a moderate or severe exacerbation were included. Missing values were imputed by linear interpolation (intermittent), backfilling (beginning) or carry forward (end). Exacerbation onset was the first day of a reported symptom of exacerbation.

          Results

          Eight hundred and eighty-eight patients in the WISDOM study had a moderate/severe exacerbation after the complete ICS withdrawal visit; 360 of them contributed at least one FEV 1 measure per week for the 8 weeks before and after the event and are included in this analysis.

          Mean daily FEV 1 began to decline from approximately 2 weeks before the onset of symptoms of an exacerbation, dropping from 0.907 L (mean Days − 56 to − 36 before the exacerbation) to 0.860 L on the first day of the exacerbation. After the exacerbation, mean FEV 1 improved but did not return to pre-exacerbation levels (mean Days 36–56 after the exacerbation, 0.875 L).

          The pattern of FEV 1 changes around exacerbations was similar in the triple therapy and dual bronchodilator groups, and a similar pattern was seen in moderate and severe exacerbations when analysed separately.

          Conclusions

          Mean lung function starts to decline prior to the first reported symptoms of an exacerbation, and does not recover to pre-exacerbation levels 8 weeks after the event.

          Trial registration

          WISDOM (ClinicalTrials.gov number, NCT00975195).

          Electronic supplementary material

          The online version of this article (10.1186/s12931-018-0944-3) contains supplementary material, which is available to authorized users.

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          Most cited references10

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          Susceptibility to exacerbation in chronic obstructive pulmonary disease.

          Although we know that exacerbations are key events in chronic obstructive pulmonary disease (COPD), our understanding of their frequency, determinants, and effects is incomplete. In a large observational cohort, we tested the hypothesis that there is a frequent-exacerbation phenotype of COPD that is independent of disease severity. We analyzed the frequency and associations of exacerbation in 2138 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study. Exacerbations were defined as events that led a care provider to prescribe antibiotics or corticosteroids (or both) or that led to hospitalization (severe exacerbations). Exacerbation frequency was observed over a period of 3 years. Exacerbations became more frequent (and more severe) as the severity of COPD increased; exacerbation rates in the first year of follow-up were 0.85 per person for patients with stage 2 COPD (with stage defined in accordance with Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages), 1.34 for patients with stage 3, and 2.00 for patients with stage 4. Overall, 22% of patients with stage 2 disease, 33% with stage 3, and 47% with stage 4 had frequent exacerbations (two or more in the first year of follow-up). The single best predictor of exacerbations, across all GOLD stages, was a history of exacerbations. The frequent-exacerbation phenotype appeared to be relatively stable over a period of 3 years and could be predicted on the basis of the patient's recall of previous treated events. In addition to its association with more severe disease and prior exacerbations, the phenotype was independently associated with a history of gastroesophageal reflux or heartburn, poorer quality of life, and elevated white-cell count. Although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype. This has implications for the targeting of exacerbation-prevention strategies across the spectrum of disease severity. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00292552.)
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            Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial

            Blood eosinophil counts might predict response to inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. We used data from the WISDOM trial to assess whether patients with COPD with higher blood eosinophil counts would be more likely to have exacerbations if ICS treatment was withdrawn.
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              • Record: found
              • Abstract: found
              • Article: not found

              Blood Eosinophils and Exacerbations in Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study.

              Whether high blood eosinophils are associated with chronic obstructive pulmonary disease (COPD) exacerbations among individuals with COPD in the general population is largely unknown.
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                Author and article information

                Contributors
                H.Watz@pulmoresearch.de
                kay.tetzlaff@boehringer-ingelheim.com
                magnussen@pulmoresearch.de
                achim.mueller@boehringer-ingelheim.com
                RORORO@clinic.cat
                e.wouters@mumc.nl
                vogelmei@med.uni-marburg.de
                pmacal@liverpool.ac.uk
                Journal
                Respir Res
                Respir. Res
                Respiratory Research
                BioMed Central (London )
                1465-9921
                1465-993X
                13 December 2018
                13 December 2018
                2018
                : 19
                : 251
                Affiliations
                [1 ]GRID grid.452624.3, Pulmonary Research Institute at Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), , German Center for Lung Research (DZL), ; Wöhrendamm 80, 22927 Grosshansdorf, Germany
                [2 ]ISNI 0000 0001 2171 7500, GRID grid.420061.1, Boehringer Ingelheim International GmbH, ; Ingelheim am Rhein, Germany
                [3 ]ISNI 0000 0001 2190 1447, GRID grid.10392.39, Department of Sports Medicine, , University of Tübingen, ; Tübingen, Germany
                [4 ]ISNI 0000 0001 2171 7500, GRID grid.420061.1, Boehringer Ingelheim Pharma GmbH & Co. KG, ; Biberach an der Riss, Germany
                [5 ]ISNI 0000 0004 1937 0247, GRID grid.5841.8, Hospital Clínic IDIBAPS-CIBERES, , Universitat de Barcelona, ; Barcelona, Spain
                [6 ]ISNI 0000 0004 0480 1382, GRID grid.412966.e, Department of Respiratory Medicine, , Maastricht University Medical Center, ; Maastricht, Netherlands
                [7 ]ISNI 0000 0004 1936 9756, GRID grid.10253.35, Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, , Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), ; Marburg, Germany
                [8 ]GRID grid.411255.6, Institute of Ageing and Chronic Disease, Clinical Science Centre, , University Hospital Aintree, ; Liverpool, UK
                Article
                944
                10.1186/s12931-018-0944-3
                6293570
                30545350
                f33528af-e243-41ec-ad07-dd905f723edd
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 20 August 2018
                : 20 November 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100008349, Boehringer Ingelheim;
                Categories
                Research
                Custom metadata
                © The Author(s) 2018

                Respiratory medicine
                copd,copd exacerbation,lung function,fev1,home-based spirometry
                Respiratory medicine
                copd, copd exacerbation, lung function, fev1, home-based spirometry

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