RT Journal Article SR Electronic T1 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with ICSs JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP erj01214-2011 DO 10.1183/09031936.00121411 A1 J. Lötvall A1 E.D. Bateman A1 E.R. Bleecker A1 W.W. Busse A1 A. Woodcock A1 R. Follows A1 J. Lim A1 S. Stone A1 L. Jacques A1 B. Haumann YR 2012 UL http://erj.ersjournals.com/content/early/2012/02/22/09031936.00121411.abstract AB Current guidelines recommend adding LABA to ICS in patients with uncontrolled asthma. This study evaluated the novel, once-daily LABA vilanterol trifenatate (VI) in asthma patients who remained symptomatic despite existing ICS therapy.Randomised, double-blind, placebo-controlled trial of VI (3, 6.25, 12.5, 25, and 50 μg), administered once daily in the evening by dry powder inhaler for 28 days, in asthma patients aged ≥12 years symptomatic on current ICS therapy. Primary endpoint: trough (24 h post-dose) FEV1; secondary endpoints: weighted mean FEV1, peak expiratory flow (PEF), symptom-/rescue-free 24-h periods, and safety.A significant relationship was observed between VI dose and improvements in trough FEV1 (p=0.037). Statistically significant increases in mean trough FEV1, relative to placebo, were documented for VI 12.5–50 μg (121–162 mL; p≤0.016). Dose-related effects of VI were observed on weighted mean (0–24 h) FEV1, morning/evening PEF, and symptom-/rescue-free 24-h periods. All doses of VI were well tolerated with low incidences of recognised LABA-related adverse events (tremor 0–2%; palpitations 0–2%; glucose effects 0–1%; potassium effects 0–<1%).Once-daily VI 12.5–50 μg resulted in prolonged bronchodilation of at least 24 h with good tolerability in asthma patients receiving ICS. Based on the overall efficacy and adverse event profile from this study the optimum dose of VI appears to be 25 μg.