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.
Abstract
Single-inhaler triple therapy for COPD provides clinical benefit across a wide spectrum of disease characteristics http://ow.ly/ETBv30iXQ97
Footnotes
This article has supplementary material available from openres.ersjournals.com
This study is registered at ClinicalTrials.gov with identifier number NCT02345161.
Conflict of interest: D.M.G. Halpin reports receiving personal fees from GSK during the conduct of the study, and personal fees and nonfinancial support from AstraZeneca, Boehringer Ingelheim and Novartis; and personal fees from Pfizer and Chiesi, outside the submitted work. R. Birk is an employee of GSK and holds shares in that company. N. Brealey is an employee of GSK and holds shares in that company. G. Criner reports receiving consulting fees from GSK and performing a contracted clinical trial for the company during the conduct of the study. He reports receiving grants from the US NIH and the Dept of Defense; receiving consulting fees from and performing contracted clinical trials for AstraZeneca, Boehringer Ingelheim, Avisa, Mereo, PneumRx/BTG, Pulmonx, Broncus and Lungpacer; receiving consulting fees from Holaira, Third Pole, Pearl, Amirall and CSA Medical; and performing contracted clinical trials for Novartis and Yungjin, all outside the submitted work. M.T. Dransfield reports receiving consulting fees from GSK and performing a contracted clinical trial for the company during the conduct of the study. He reports receiving grants from the US National Institutes of health and the Dept of Defense; receiving consulting fees from and performing contracted clinical trials for AstraZeneca, Boehringer Ingelheim and Boston Scientific; receiving consulting fees from Genentech; and performing contracted clinical trials for Novartis, Pulmonx, PneumRx/BTG and Yungjin, all outside the submitted work. E. Hilton is an employee of GSK and holds shares in that company. D.A. Lomas reports receiving grants, personal fees and nonfinancial support from GSK during the conduct of the study; personal fees and grants from GSK; and personal fees from Griffols, all outside the submitted work. C-Q. Zhu is an employee of GSK and holds shares in that company. D.A. Lipson is an employee of GSK and holds shares in that company.
Support statement: This study was funded by GSK (ClinicalTrials.gov identifier NCT02345161; GSK study number CTT116853). Funding information for this article has been deposited with the Crossref Funder Registry.
- Received September 26, 2017.
- Accepted March 9, 2018.
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