Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial

Abstract

Introduction

Fluticasone furoate (FF)/vilanterol (VI) dry powder inhaler (DPI) is the only once-daily maintenance inhaled corticosteroid (ICS)/long-acting β2 adrenergic agonist (LABA) combination for asthma. We aimed to compare the clinical effects of once-daily FF/VI and twice-daily budesonide (BUD)/formoterol (FM) DPI in patients with controlled stable asthma.

Methods

We performed a randomized crossover trial in which stable asthmatic patients controlled on ICS/LABA received 8 weeks of FF/VI (100/25 μg 1 puff once-daily) or BUD/FM (160/4.5 μg 2 puffs twice-daily) DPI treatment. After a 4–8-week washout period, patients received another crossover treatment for 8 weeks. We assessed pulmonary function, the 5-item version asthma control questionnaire (ACQ5), the asthma control test (ACT), and fractional exhaled nitric oxide (FeNO) at baseline and after 8 weeks of treatment (week 8). As the primary outcome was change in force expiratory volume in 1 s (FEV₁) between baseline and week 8, we evaluated the incidence of asthma exacerbation and adherence barrier questionnaire (Ask-12) at week 8.

Results

Twenty-three patients were initially enrolled in this study; however, one patient had to be excluded. The FF/VI DPI treatment group showed a similar magnitude of change in FEV₁ between baseline and week 8 as the BUD/FM DPI treatment group. In addition, there were no significant differences in pulmonary function tests, ACQ5 scores, ACT scores, and FeNO between baseline and week 8 in both groups. Although the incidence of exacerbation did not differ between groups, the Ask-12 score in the FF/VI DPI group was significantly lower than that in the BUD/FM DPI group.

Conclusions

The present study indicates that once-daily FF/VI DPI is not inferior to twice-daily BUD/FM DPI in clinical effect and more likely to improve inconvenience and forgetfulness in inhalation adherence barriers for stable asthma control therapy. Once-daily FF/VI DPI may be an effective alternative for asthma maintenance treatment.

Keywords:

• fluticasone furoate/vilanterol
• budesonide/formoterol
• stable asthma
• randomized crossover trial
• inhalation adherence barriers

Acknowledgment

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Abbreviations

ACQ5, 5-item version asthma control questionnaire; ACT, asthma control test; Ask-12, adherence barrier questionnaire; BUD, budesonide; COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; FeNO, fractional exhaled nitric oxide; FEV₁, force expiratory volume in 1 s; FF, fluticasone furoate; FM, formoterol; FP, fluticasone propionate; FVC, forced vital capacity; GC, glucocorticoid; ICS, inhaled corticosteroid; LABA, long-acting β2 adrenergic agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; MMF, maximum mid-expiratory flow rate; SABA, short-acting β2 adrenergic agonist; SLM, salmeterol; V₂₅, maximum expiratory flow rate at 25%; V₅₀, maximum expiratory flow rate at 50%; VI, vilanterol.

Availability of data and material

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Consent for publication

All patients provided written informed consent.

Ethics approval and consent to participate

The study protocol was approved by the institutional review board of Hamamatsu University School of Medicine (HUSM 14-146). The trial was registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN ID 000015609).

Author contributions

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.