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Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

Halpin, DMG; Birk, R; Brealey, N; Criner, GJ; Dransfield, MT; Hilton, E; Lomas, DA; ... Lipson, DA; + view all (2018) Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses. ERJ Open Research , 4 (2) , Article 00119-2017. 10.1183/23120541.00119-2017. Green open access

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Abstract

Triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear. FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg using the Ellipta inhaler with twice-daily budesonide/formoterol (BUD/FOR) 400/12 µg using the Turbuhaler. Subgroup analyses of forced expiratory volume in 1 s (FEV1), St George's Respiratory Questionnaire (SGRQ) Total score and exacerbation rates were carried out. Subgroups were defined by COPD medication at screening (ICS+LABA, BUD+FOR, ICS+LABA+LAMA, LAMA alone, tiotropium alone and LAMA+LABA), by disease severity (lung function and exacerbations) and by exacerbation history (exacerbation severity and frequency). In the intent-to-treat population (n=1810) at week 24, FF/UMEC/VI (n=911) versus BUD/FOR (n=899) improved FEV1 and SGRQ Total score and reduced mean annual exacerbation rates in all disease severity and exacerbation history subgroups. FF/UMEC/VI versus BUD/FOR improved FEV1 and SGRQ Total score in all medication subgroups and reduced mean annual exacerbation rates in all medication subgroups, except LAMA+LABA. Adverse events were similar across subgroups. These findings support the benefit of FF/UMEC/VI compared with dual ICS/LABA therapy in patients with symptomatic COPD regardless of disease severity or prior treatment and may help to inform clinical decision making.

Type: Article
Title: Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1183/23120541.00119-2017
Publisher version: https://doi.org/10.1183/23120541.00119-2017
Language: English
Additional information: Copyright © The content of this work is copyright of the authors or their employers. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0 (https://creativecommons.org/licenses/by-nc/4.0/).
UCL classification: UCL
UCL > Provost and Vice Provost Offices > VP: Health
URI: https://discovery.ucl.ac.uk/id/eprint/10051875
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