Efficacy and Safety of Fluticasone Furoate/Vilanterol Compared With Fluticasone Propionate/Salmeterol Combination in Adult and Adolescent Patients With Persistent Asthma

Abstract

Background:The combination of fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting β2 agonist, is under development as a once-daily treatment of asthma and COPD. The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on a medium dose of ICS.Methods:In a randomized, double-blind, double-dummy, parallel group study, 806 patients received FF/VI (100/25 μg, n = 403) once daily in the evening delivered through ELLIPTA (GlaxoSmithKline) dry powder inhaler, or FP/SAL (250/50 μg, n = 403) bid through DISKUS/ACCUHALER (GlaxoSmithKline). The primary efficacy measure was 0- to 24-h serial weighted mean (wm) FEV1 after 24 weeks of treatment.Results:Improvements from baseline in 0- to 24-h wmFEV1 were observed with both FF/VI (341 mL) and FP/SAL (377 mL); the adjusted mean treatment difference was not statistically significant (−37 mL; 95% CI, −88 to 15, P = 0.162). There were no differences between 0- to 4-h serial wmFEV1, trough FEV1, and asthma control and quality-of-life questionnaire scores. There was no difference in reported exacerbations between treatments. Both treatments were well tolerated, with no clinically relevant effect on urinary cortisol excretion or vital signs and no treatment-related serious adverse events.Conclusions:The efficacy of once-daily FF/VI was similar to bid FP/SAL in improving lung function in patients with persistent asthma. No safety issues were identified.Trial registry:ClinicalTrials.gov; No.: NCT01147848; URL: www.clinicaltrials.gov

Future treatment for asthma

“…Other routes of administration have been tested and the concept of unified airways was reinforced by a successful attempt where nasal administration was significantly efficacious in improving airway inflammation [59][60][61][62].…”

“…The recently developed once-daily, very long-acting LABA (indacaterol, vilanterol, olodaterol and others [62][63][64][65][66]) potentially offer better bronchodilation patterns relevant to treating severe asthma with persistent airflow obstruction. Whether these drugs will also synergistically improve asthma control and reduce exacerbation rates is unknown at present.…”

The combination of fluticasone furoate and vilanterol trifenatate in the management of asthma: clinical trial evidence and experience

“…However, the combination of LABA/ICS significantly improved lung function and reduced symptoms and the need for rescue SABA use compared with ICS alone [Ni Chroinin et al 2009]. A recent large study of up to 78 weeks in 2019 patients with asthma aged 12 years or over who had had at least one asthma exacerbation in the previous year showed a reduced risk of exacerbations and improved lung function with a combined ICS/LABA compared with just an ICS [Bateman et al 2013]. There were only two deaths in the ICS alone group (pneumonia and cancer) and one in the ICS/ LABA combination inhaler group (automobile accident).…”

New drugs: Fluticasone furoate with vilanterol

“…This difference is not statistically significant and there was also no difference in asthma control or exacerbations. 3 …”

“…The comparative study in asthma suggests that fluticasone furoate/vilanterol 100/25 microgram once daily is similar to fluticasone propionate/salmeterol 250/50 microgram twice daily. 3 A once-daily dose may help some patients adhere to their treatment. The fluticasone furoate/vilanterol combination is not indicated for treating acute symptoms, so patients will still need a short-acting beta agonist.…”