Fluticasone furoate + vilanterol superior to usual care in improving asthma control
Initiating therapy with fluticasone furoate plus vilanterol resulted in improved asthma control over usual care in individuals with symptomatic asthma, according to results of the Salford Lung Study presented at ERS 2017.
“[T]his is the first time the [fluticasone furoate plus vilanterol] combination has shown additional benefits, in terms of asthma control, when compared with optimized usual care in a broad patient population,” said the researchers.
Patients aged ≥18 years (n=4,233, mean age 50 years, 59 percent female) from 74 GP clinics in Salford and South Manchester, UK, with GP-diagnosed symptomatic asthma and on maintenance therapy (inhaled corticosteroids with or without a long-acting β-agonist) were randomized to receive once-daily inhaled doses of fluticasone furoate (100 or 200 µg) plus vilanterol (25 µg, n=2,114) or optimized usual care (n=2,119) and were followed up for 12 months.
The primary effectiveness analysis population consisted of patients with ACT score <20 at baseline; 1,207 patients with scores ≥20 (602 and 605 in the fluticasone furoate plus vilanterol and usual care groups, respectively) were thus excluded from the primary analysis. Patients who had been randomized to fluticasone furoate plus vilanterol could add on or replace this treatment with other asthma medications while those randomized to usual care could change to other medications except for fluticasone furoate plus vilanterol. Twenty-two and 18 percent of patients on fluticasone furoate plus vilanterol and usual care, respectively, changed medications.
In the primary effectiveness analysis population, at 24 weeks, patients assigned to fluticasone furoate plus vilanterol had a higher likelihood of being responders (asthma control test [ACT] score ≥20 or increase by ≥3 points from baseline) compared with patients on usual care (71 percent vs 56 percent; odds ratio [OR], 2.00, 95 percent confidence interval [CI], 1.70–2.34; p<0.0001). These findings were sustained throughout the follow-up period (OR, 2.04, 1.77, and 1.83 at weeks 12, 40, and 52, respectively; p<0.0001 for all). [Lancet 2017;doi:10.1016/S0140-6736(17)32397-8; ERS 2017, abstract OA 3193]
The findings were similar in the analysis of the total population at week 24 (74 percent vs 60 percent; OR, 1.97, 95 percent CI, 1.71–2.26; p<0.0001).
Mean ACT score in the primary analysis population at 24 weeks was also more elevated in patients on fluticasone furoate plus vilanterol compared with those on usual care (mean increase from baseline, 4.4 vs 2.8; difference, 1.6, 95 percent CI, 1.3–2.0; p<0.0001), while adjusted annual exacerbation rate did not significantly differ between groups (p=0.6969).
“[O]ur data suggest that there are other important factors underlying asthma exacerbations in the everyday care setting, which are independent of asthma control and not present in a tightly controlled efficacy trial,” said the researchers.
When accounting for treatment modification, incidence of pneumonia was low and comparable between groups; however, according to randomized group, pneumonia incidence was higher among patients assigned to fluticasone furoate plus vilanterol compared with usual care (n=23 vs 16).
The researchers acknowledged that the open-label design may have affected the results and highlighted the role of effectiveness trials in routine care in influencing clinical guidelines for chronic diseases.
“Embedded within a primary care setting, [this trial] assesses important patient outcomes by use of the existing electronic health record … [it] gives estimates of what might be expected to happen when you treat the next patient with asthma in your clinic,” said Professor Peter Gibson from the John Hunter Hospital, New South Wales, Australia, in a commentary. [Lancet 2017;doi:10.1016/S0140-6736(17)32398-X]