Fluticasone furoate and vilanterol inhalation powder for the treatment of chronic obstructive pulmonary disease

Abstract

Fluticasone furoate/vilanterol (FF/VI) is a novel inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) fixed dose combination that, by simplifying the dosing schedule, allows, for the first time in a member of the ICS/LABA class, a shift from twice-daily to once-daily treatment. FF/VI is delivered via a novel, single-step activation, multi-dose dry powder inhaler for oral inhalation, Ellipta™. Regrettably, there are no head-to-head trials that have shown superiority in the safety or efficacy of FF versus other ICSs, but evidence shows that VI has a quicker onset of effect versus salmeterol. However, the clinical utility of this effect in a maintenance medication is still questionable. Furthermore, benefits of FF/VI over twice-daily ICS/LABA comparator have not been shown yet and, in addition, its adverse event profile is generally consistent with the known class effects of an ICS/LABA fixed dose combination. In particular, there is an increase in the risk of pneumonia among patients treated with FF/VI relative to VI, mainly among those who benefit most from FF/VI. Nevertheless, the interesting pharmacological profiles of both FF and VI, the possibility that FF/VI can be administered once-daily, and the attractive characteristics of Ellipta™ are important features that could help FF/VI to be a successful combination in the treatment of chronic obstructive pulmonary disease.

Keywords:

• COPD
• Ellipta
• fixed-dose combination
• fluticasone furoate
• vilanterol

Financial & competing interests disclosure

M Cazzola is a member of a scientific board at GSK and is a consultant at GSK Italia. 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.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The efficacy of combination therapy with an inhaled long-acting β₂-agonist (LABA) plus a low dose of an inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD) has been well documented.

• There is a strong interest in developing a once-daily ICS/LABA fixed-dose combination therapy, in an attempt to simplify the treatment and, thus, increase adherence to the prescribed therapy.

• Fluticasone furoate/vilanterol (FF/VI) is a novel ICS/LABA fixed-dose combination that, by simplifying the dosing schedule, allows, for the first time, a shift from twice-daily to once-daily treatment, with an acceptable safety and tolerability profile that is consistent with the ICS/LABA class.

• Contribution of VI to FF/VI in COPD patients has been demonstrated on 0–4 hr weighted mean FEV1, whereas contribution of FF to FF/VI has been demonstrated by reductions in annual rate of moderate and severe exacerbations.

• FF/VI is delivered via a novel, single-step activation, multidose dry powder inhaler for oral inhalation, Ellipta™.

• The pharmacological profiles of FF and VI, the possibility that FF/VI can be administered once daily and the attractive characteristics of Ellipta™ are important features that could help FF/VI become a successful combination in the treatment of COPD.