Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study

Figures & data

Figure 1. Patient flow through study.

Notes. ACT: Asthma Control Test; AE: adverse event; AQLQ: Asthma Quality of Life Questionnaire; FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; PD: protocol deviation; WPAI: asthma: Work Productivity and Activity Impairment: Asthma questionnaire. ^aThe total population includes all randomly assigned patients who received at least one prescription of study medication, were included in the ICS/LABA stratum and whose prerandomisation intended prescription was FP/Salm. ^bWeek 24 AQLQ data are not reported for this FP/Salm subset analysis. Other endpoints, including safety, exacerbations and prescribed/dispensed/collected medications, were captured throughout the study.

Table 1. Patient demographics and baseline asthma characteristics (total population).

Characteristic	FF/VI (n = 646)	FP/Salm (n = 618)
Age, years
Mean (SD)	51.8 (15.0)	51.0 (16.2)
Range	18–89	18–88
Female, n (%)	377 (58)	375 (61)
Duration of asthma ≥10 years, n (%)	504 (78)	486 (79)
Daytime symptoms more than twice a week, n (%)^a	593 (92)	572 (93)
Activity limitations in past week, n (%)^a	362 (56)	352 (57)
Night-time symptoms in past week, n (%)^a	341 (53)	351 (57)
Exacerbation(s) in 12 months prior to randomisation, n (%)
0	365 (57)	330 (53)
1	161 (25)	157 (25)
>1	120 (19)	131 (21)
Mean (SD)	0.8 (1.36)	0.9 (1.34)
Baseline ACT score, mean (SD)	15.5 (4.6)	15.3 (4.7)

Notes. ACT: Asthma Control Test; FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; SD: standard deviation.

^aBased on patients’ recall of symptoms in the previous week as assessed at the baseline (randomisation) visit.

Figure 2. ACT responders over time in the FF/VI and FP/Salm groups (total population).^a.b

Notes. ACT: Asthma Control Test; CI: confidence interval; FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; OR: odds ratio. ^aResponders defined as patients who achieved an ACT total score of ≥20 and/or improvement from baseline of ≥3 points. ^bLogistic regression analysis adjusting for randomised treatment, baseline ACT total score, baseline ACT total score squared, gender, and age.

Figure 3. LS mean change from baseline in ACT total score over time in the FF/VI and FP/Salm groups (total population).^a

Notes. ACT: Asthma Control Test; CI: confidence interval; FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; LS: least squares; SE: standard error. ^aMixed model repeated measures analysis adjusted for randomised treatment, baseline ACT total score, randomised treatment-by-baseline ACT total score interaction, gender, age, visit and randomised treatment-by-visit interaction with an unstructured covariance matrix.

Figure 4. Percentage of responders for AQLQ total score and individual AQLQ domains in the FF/VI and FP/Salm groups (total population).^a,b

Notes. AQLQ: Asthma Quality of Life Questionnaire; CI: confidence interval; FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; OR: odds ratio. ^aResponders defined as patients with a change from baseline of ≥0.5 points in AQLQ total score or AQLQ domain score. ^bLogistic regression analysis adjusting for randomised treatment, ACT total score at baseline per randomisation stratum, gender, age and baseline AQLQ score.

Table 2. On-treatment SAEs of special interest (total population).

SAE of special interest group, events (rate per 1000 patient-years)	Actual treatment FF/VI (n = 648)^a	Actual treatment^b FP/Salm (or other ICS or ICS/LABA) (n = 739)^a
Cardiovascular disease	15 (27.3)	24 (34.9)
Decreased bone mineral density and associated fractures	13 (23.7)	16 (23.3)
Asthma/bronchospasm	4 (7.3)	16 (23.3)
Pneumonia	6 (10.0)	6 (8.2)
Lower respiratory tract infection excluding pneumonia	3 (5.5)	5 (7.3)
Effects on glucose	8 (14.6)	5 (7.3)
Hypersensitivity	3 (5.5)	2 (2.9)
Effects on potassium	2 (3.6)	0
Corticosteroid-associated eye disease	5 (9.1)	4 (5.8)
Adrenal suppression	0	1 (1.5)
Local steroid effects	1 (1.8)	0
Tremor	0	0

Notes. Data presented by current treatment and given as number of events with rates per 1000 patient-years in brackets. FF/VI: fluticasone furoate/vilanterol; FP/Salm: fluticasone propionate/salmeterol; ICS: inhaled corticosteroid; LABA: long-acting beta₂-agonist; SAE: serious adverse event.

^a Number of patients with at least one SAE of special interest while at risk for that class of treatment. ^bIncludes patients in FF/VI randomisation arm who had modified their treatment and were receiving other ICS or ICS/LABA at the time of the event. This column also includes all patients randomised to FP/Salm, regardless of whether they were receiving FP/Salm or another ICS or ICS/LABA at the time of the event.