• Nawar Diar Bakerly, Ashley Woodcock, Susan Collier, David A Leather, John P New, Jodie Crawford, Catherine Harvey, Jørgen Vestbo, and Isabelle Boucot.
• Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK; Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester, M13 9PL, UK. Electronic address: nawar.bakerly@srft.nhs.uk.
• Respir Med. 2019 Feb 1; 147: 58-65.

BackgroundSLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups.MethodsPatients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months' follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed.ResultsLower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (-0.5% [-29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [-0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA.ConclusionsInitiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

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