A recent study published in The Lancet attempted to better characterize the efficacy of fluticasone furoate plus vilanterol in asthma control in clinical practice.
Using an open-label randomized controlled 2-arm effectiveness design, the Salford Lung Study (An Effectiveness Study Comparing Fluticasone Furoate [FF, GW685698]/Vilanterol [VI, GW64244] With Standard Treatment in Asthma; ClinicalTrials.gov identifier: NCT01706198) was conducted at 74 general practice clinics in the United Kingdom. Investigators randomly assigned patients to treatment with fluticasone furoate plus vilanterol (n=2114) or usual care (n=2119). The primary outcome was the percentage of patients who scored ≥20 on an asthma control test (ACT) or an increase in ACT score from baseline of ≥3 (in patients who had scores <20) at 24 weeks.
At week 24, the odds of responding to treatment were higher in the fluticasone furoate plus vilanterol group, with a response rate of 71% compared with the usual care group (56%); (odds ratio, 2.00; 95% CI, 1.70-2.34; P <.0001). The adjusted mean ACT score increased 4.4 points from baseline in the intervention group compared with 2.8 points in the usual care group (difference, 1.6; 95% CI, 1.3-2.0; P <.0001). Serious adverse events were comparable in both groups, and pneumonia was uncommon. The treatment benefit was consistent for the entire 52-week study duration.
Study limitations included the potential for bias due to the open-label design and the choice of a “soft” primary outcome such as the ACT score, which relies on patient perception. In addition, there was a large degree of treatment modification during the first 3 months in the fluticasone furoate and vilanterol group, primarily due to patients choosing to return to a long-standing treatment.
Nonetheless, given the enduring benefit observed in the intervention group, the findings suggest that patients in general practice with a diagnosis of symptomatic asthma can achieve improved asthma control from the use of once-daily combination therapy with fluticasone and vilanterol without incurring additional risk for serious adverse events.
Disclosures: The Salford Lung Study was funded by GlaxoSmithKline. Several investigators report financial support from GlaxoSmithKline as well as other pharmaceutical companies.
Woodcock A, Vestbo J, Bakerly ND, et al; on the behalf of the Salford Lung Study Investigators. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial [published online September 10, 2017]. Lancet. doi:10.1016/S0140-6736(17)32397-8