RT Journal Article
SR Electronic
T1 Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00119-2017
DO 10.1183/23120541.00119-2017
VO 4
IS 2
A1 David M.G. Halpin
A1 Ruby Birk
A1 Noushin Brealey
A1 Gerard J. Criner
A1 Mark T. Dransfield
A1 Emma Hilton
A1 David A. Lomas
A1 Chang-Qing Zhu
A1 David A. Lipson
YR 2018
UL http://openres.ersjournals.com/content/4/2/00119-2017.abstract
AB 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.Single-inhaler triple therapy for COPD provides clinical benefit across a wide spectrum of disease characteristics http://ow.ly/ETBv30iXQ97