A single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD

ABSTRACT

Introduction

Single inhaler triple therapy (SITT) with an inhaled corticosteroid, a long-acting β₂-agonist, and a long-acting muscarinic antagonist is an effective and attractive therapeutic option codified in the recommendations of guidelines and treatment strategies for the management of COPD.

Areas covered

The preclinical and clinical development in COPD of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) SITT and its use in the real world.

Expert opinion

Findings from phase III/IV trials and the use of FF/UMEC/VI in the real-world setting support the view that it may be a useful, safe, and cost-effective option for the maintenance treatment of COPD, especially when dealing with patients who are not adequately controlled with dual ICS/LABA or LAMA/LABA therapy. Only direct head-to-head comparisons will be able to establish whether FF/UMEC/VI may be preferable to the other SITTs approved for COPD due to its pharmacokinetic and pharmacodynamic characteristics and especially the fact that it is the only one that can be taken once-daily. In addition, there is a need for further studies, especially in the real world, to optimize the positioning of FF/UMEC/VI in the treatment of COPD, also considering the availability of FF/VI and UMEC/VI and the need for better differentiation between the three treatments.

KEYWORDS:

• COPD
• single inhaler triple therapy
• fluticasone furoate
• umeclidinium
• vilanterol

Article highlights

• The use of SITT with an ICS, a LAMA, and a LABA is now codified in the main guidelines or strategies for the treatment of COPD.

• FF/UMEC/VI, formulated in the Ellipta inhaler, is a once-daily SITT approved for COPD treatment by the FDA and the EMA.

• An extensive clinical program, which included the pivotal FULFIL and IMPACT trials, enrolled many patients.

• FF/UMEC/VI produced statistically and clinically significant improvements in lung function, dyspnea and HRQoL, significantly reduced the risk of CID and moderate/severe exacerbations rate compared to FF/VI or UMEC/VI and lowered the risk of all-cause mortality versus LABA/LAMA in patients with symptomatic COPD and a history of exacerbations.

• There is evidence that the higher the level of BEC, the greater the effect of FF/UMEC/VI.

• FF/UMEC/VI SITT significantly improved health status and lung function compared to other TTs delivered using multiple inhalers.

Declaration of interest

M Cazzola, P Rogliani, J Ora and MG Matera were faculty members and advisors in scientific meetings sponsored by GlaxoSmithKline, which manufactures fluticasone furoate/umeclidinium/vilanterol. GlaxoSmithKline also funded MG Matera’s department. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.