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dc.contributor.authorSiddiqui, SH-
dc.contributor.authorPavord, ID-
dc.contributor.authorBarnes, NC-
dc.contributor.authorGuasconi, A-
dc.contributor.authorLettis, S-
dc.contributor.authorPascoe, S-
dc.contributor.authorPetruzzelli, S-
dc.identifier.citationInternational Journal of Chronic Obstructive Pulmonary Disease, 2018, 13, pp. 3669-3676en
dc.descriptionThe manuscript reports results from an analysis of three studies: “FORWARD” NCT00929851 (Chiesi) and replicate Dransfield studies NCT01009463/NCT01017952 (GSK). For GSK clinical trials, within 6 months of publishing the results of the primary endpoints of the study, anonymized individual participant data plus the annotated case report form, protocol, reporting and analysis plan, data set specifications, raw dataset, analysis-ready dataset, and clinical study report are available for research proposals approved by an independent review committee. Proposals should be submitted to www. A data access agreement will be required. From January 1, 2019, Chiesi commits to sharing the anonymized, patient-level data, study-level data, the clinical protocol, and the full clinical study report of the FORWARD study (NCT00929851) with qualified scientific and medical researchers, conducting legitimate research. Chiesi provides access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Fundamental conditions for providing the requested clinical trial data are that qualified researchers agree to sign a Data Sharing Agreement, to use the data only for noncommercial purposes and to seek publication of their research results. Other information on Chiesi’s data sharing commitment, access and research request’s approval process will be available from January 1, 2019, in the Clinical Trial Transparency section of this webpage page: http://
dc.description.abstractBackground: Growing evidence suggests that blood eosinophil count is associated with patient responsiveness to inhaled corticosteroids (ICS). We performed post hoc predictive modeling on data from the FORWARD study and two replicate studies by Dransfield, to evaluate the relationships between baseline eosinophil count and the effect of ICS on exacerbations and lung function in patients with COPD. Methods: The studies assessed ICS/long-acting β2 agonist (LABA) combinations vs LABA alone. Using data from each study, we modeled COPD exacerbation rates, predose FEV1, and St George's Respiratory Questionnaire score ([FORWARD only]) over a continuous range of eosinophils (0-1,000 eosinophils/µL in FORWARD, 0-993 eosinophils/µL in Dransfield). Results: In all studies, ICS/LABA reduced exacerbations versus LABA alone across all eosinophil levels, with progressively greater reductions at increasing baseline blood eosinophil counts. In FORWARD, annual exacerbation rates ranged from 0.78 to 0.83 per year between 0 and 1,000 eosinophils/µL in the ICS/LABA arm, and from 0.81 to 1.54 per year in the LABA-only arm. In the Dransfield studies, exacerbation rates ranged from 0.54 to 1.02 per year in the ICS/LABA arm between 0 and 993 eosinophils/µL, and from 0.56 to 1.75 per year in the LABA-only arm. Change in FEV1 was not associated with eosinophil count in ICS-treated patients in FORWARD, whereas an increased treatment benefit in terms of FEV1 was observed at higher eosinophil levels in the Dransfield studies. ICS/LABA led to greater improvements in St George's Respiratory Questionnaire total scores compared to LABA alone in patients in FORWARD with ≥67 eosinophils/µL. Conclusion: Higher blood eosinophil count in patients with COPD is associated with an increased beneficial effect from ICS in terms of exacerbation reduction. Further prospective data are required to assess the role of blood eosinophils as a biomarker for therapeutic recommendations.en
dc.description.sponsorshipThe authors would like to thank Amy Newlands, statistician at GSK, who performed the analyses. Editorial support (in the form of writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing) was provided by Catherine Elliott and David Mayes at Gardiner-Caldwell Communications (Macclesfield), and was funded by GSK. The abstract of this paper was presented at the European Respiratory Society International Congress 2016 as an oral presentation with interim findings. The abstract was published in the Eur Respir J. 2016;48(60):OA1763: content/48/suppl_60/OA1763. This analysis was sponsored by GlaxoSmithKline plc (NCT01009463/NCT01017952) and Chiesi Farmaceutici SpA (NCT00929851) and was supported by the Leicester National Institute for Health Research (NIHR) Biomedical Research Centre: Respiratory Theme. The sponsors participated in the conception and design of the study, analysis and interpretation of the data, drafting and critical revision of the report, and approved submission of the manuscript. All authors had access to the results of the analyses, reviewed and edited the manuscript, approved the final draft, and were involved in the decision to submit the manuscript for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.en
dc.publisherDove Medical Pressen
dc.rightsCopyright © the authors, 2018. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-commercial License (, which permits unrestricted use, distribution, and reproduction in any medium non-commercially, provided the original author and source are credited.en
dc.subjectlung functionen
dc.titleBlood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids.en
dc.typeJournal Articleen
dc.description.versionPublisher Versionen
dc.type.subtypeJournal Article-
pubs.organisational-group/Organisation/COLLEGE OF LIFE SCIENCESen
pubs.organisational-group/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicineen
pubs.organisational-group/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Infection, Immunity and Inflammationen
Appears in Collections:Published Articles, Dept. of Infection, Immunity and Inflammation

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