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

Figures & data

Figure 1 Study design. Stable asthmatic patients received 8 weeks of fluticasone furoate/vilanterol (FF/VI) dry powder inhaler (DPI) (100/25 μg 1 puff once-daily) or budesonide/formoterol (BUD/FM) DPI (160/4.5 μg 2 puffs twice-daily) 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). The incidence of asthma exacerbation and an adherence barrier questionnaire (Ask-12 survey) were evaluated at week 8.

Table 1 Patient characteristics

	All subjects (n=22)
Age (years)*	62.0±12.0
Gender (Male/Female)	8/14
BMI (kg/m^2)*	23.9±4.52
Smoking status (Former/Never)	7/15
Smoking amount (pack-years)*	1.19±2.73
Duration of asthma (years)*	24.5±19.2
Atopic asthma	18 (81.8%)
Comorbid allergic rhinitis	15 (68.2%)
Asthma exacerbation history: number in previous 12 months
0	21 (95.5%)
1	1 (4.5%)

Note: *Mean ± standard deviation (SD).

Abbreviation: BMI, body mass index.

Table 2 Patient treatment at the registration

	All subjects (n=22)
Duration of treatment with BUD/FM (months)*	17.5±14.0
Concomitant medication
Leukotriene receptor antagonist	8 (36.4%)
Antihistamines	5 (22.7%)

Note: *Mean ± standard deviation (SD).

Abbreviation: BUD/FM, budesonide/formoterol.

Table 3 Incidence of asthma exacerbation

	BUD/FM 640/18 μg	FF/VI 100/25 μg	p-value
Asthma exacerbation	1/22 (4.6%)	2/22 (9.1%)	0.5498

Abbreviations: BUD/FM, budesonide/formoterol; FF/VI, fluticasone furoate/vilanterol.

Table 4 Change in parameters from baseline to after 8 weeks of treatment

	BUD/FM 640/18 μg (n=21)			FF/VI 100/25 μg (n=20)			#p-value
	Baseline	After	*p-value	Baseline	After	*p-value
FVC (L)	2.79±0.73	2.85±0.67	0.216	2.86±0.63	2.85±0.72	0.815	0.258
%FVC (%)	97.1±15.7	99.8±16.1	0.102	98.6±16.0	98.0±16.8	0.662	0.116
FEV1 (L)	2.07±0.53	2.10±0.51	0.341	2.15±0.54	2.08±0.54	0.397	0.203
%FEV1 (%)	88.4±15.4	90.4±16.7	0.163	90.7±18.0	89.8±21.2	0.688	0.185
FEV1/FVC (%)	74.7±10.3	75.8±10.5	0.328	75.6±11.0	75.2±11.2	0.644	0.291
MMF (L/s)	1.73±0.97	1.77±1.09	0.672	1.90±1.07	1.93±1.11	0.754	0.922
%MMF (%)	60.0±28.0	61.3±30.6	0.654	64.8±29.8	67.9±34.1	0.292	0.681
V50 (L/s)	2.27±1.11	2.28±1.14	0.911	2.35±1.12	2.36±1.22	0.965	0.985
%V50 (%)	68.6±28.0	69.2±28.4	0.842	70.3±28.4	74.6±36.4	0.284	0.456
V25 (L/s)	0.69±0.54	0.72±0.63	0.492	0.78±0.63	0.74±0.56	0.362	0.256
%V25 (%)	54.5±31.8	56.7±37.8	0.478	58.9±37.9	58.9±38.0	0.986	0.626
ACQ5	0.35±0.42	0.39±0.51	0.748	0.29±0.41	0.39±0.54	0.180	0.402
ACT	23.3±2.10	23.6±2.21	0.352	23.8±1.83	23.5±1.96	0.425	0.219
FeNO (ppb)	23.5±17.4	25.7±17.7	0.150	26.1±19.5	24.3±19.6	0.407	0.253

Notes: All baseline and after treatment values are presented as mean ± standard deviation (SD); *comparison between baseline and after treatment values in each group by paired T-test; #comparison between BUD/FM and FF/VI by multivariate analysis of variance.

Abbreviations: BUD/FM, budesonide/formoterol; FF/VI, fluticasone furoate/vilanterol; FVC, forced vital capacity; FEV₁, force expiratory volume in 1 s; MMF, maximum mid-expiratory flow rate; V₅₀, maximum expiratory flow rate at 50%; V₂₅, maximum expiratory flow rate at 25%; ACQ5, 5-item version asthma control questionnaire; ACT, asthma control test; FeNO, fractional exhaled nitric oxide.

Table 5 Scoring of Ask-12 adherence barrier survey

Ask-12 scales	BUD/FM 640/18 μg (n=21)	FF/VI 100/25 μg (n=20)	p-value
Adherence-related subscales
Inconvenience/forgetfulness	7.05±2.69	5.40±2.93	0.0425
Health beliefs	8.90±3.02	7.40±2.72	0.0998
Behavior	8.14±4.02	6.40±2.21	0.0630
Total score	24.1±8.60	19.3±5.71	0.0366

Note: All values are presented as mean ± standard deviation (SD).

Abbreviations: BUD/FM, budesonide/formoterol; FF/VI, fluticasone furoate/vilanterol.

Availability of data and material

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