Once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) is non-inferior when compared with twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adolescents and adults with asthma that is well controlled on inhaled corticosteroid/long-acting ß2 agonist (ICS/LABA). The results were published in the Journal of Asthma.
“The majority of approved combinations [of ICS/LABA for the treatment of persistent asthma in adolescents and adults] are indicated for twice-daily (BID) administration; however, FF/VI is indicated for once-daily (OD) administration,” wrote primary author David Bernstein, MD, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, OH. “Reducing the frequency of inhaler use from BID to OD [once daily] administration could simplify treatment, improve convenience for patients, and improve treatment adherence.”
In the current Phase 3a non-inferiority trial, the researchers primarily examined lung function and tolerability in 1,504 intent-to-treat (ITT) patients (mean age: 43.5 years; 64% female) randomized to one of three treatment groups: FF/VI, FP/SAL, or twice-daily FP 250 μg for 24 weeks.
Asthma patients in this study were ≥ 12 years of age, were either men or non-pregnant women, had an FEV1 of ≥ 80% of the predicted normal value, and received ICS/LABA at minimum 12 weeks before the beginning of the study.
The primary endpoint was the change in FEV1 evening-trough levels between baseline and the end of the 24-week study period. Secondary endpoints were the changes between baseline and 24 weeks in the percentage of rescue-free and symptom-free 24-hour periods, and in morning and evening peak expiratory flow. Another secondary endpoint was the percentage of patients with controlled asthma as demonstrated by an Asthma Control Test (ACT) Score of ≥ 20 after 24 weeks.
The treatment difference between FF/V1 and FP/SAL FEV1 evening-trough levels at the end of the 24-week treatment period suggested that FF/V1 was non-inferior to FP/SAL. Specifically, the treatment difference between FF/V1 and FP/SAL was 19 mL (95% CI: −11 to 49) in the ITT population and 6 mL (95% CI: −27 to 40) in the per protocol (PP) population, with both lower bounds of the 95% CIs exceeding the pre-defined non-inferiority margin of –100 mL.
According to the authors, this primary endpoint “was supported by the secondary/other efficacy endpoints, whereby findings for rescue-free and symptom-free 24-hour periods, morning/evening PEF, ACT scores and AQLQ (12+) scores were all similar for FF/VI compared with FP/SAL.”
Moreover, all secondary and other endpoints favored FF/V1 vs FP/SAL, with the exception of ACT Score ≥ 20.
All three treatments were well tolerated by the patients, and adverse events were comparable among the different arms.
One limitation of this study was that 48% of the initial patient population failed the screening. Since the study was so highly selective, the generalizability of results could be limited.
“Our findings, demonstrating the non-inferiority of FF/VI to FP/SAL,” concluded the authors, “suggest that patients with asthma already well controlled on FP/SAL could step across to FF/VI without loss of efficacy, giving physicians and/or patients the option of a once-daily ICS/LABA if preferred.”
This research was funded by GlaxoSmithKline.
To read more about this study, click here.