PT - JOURNAL ARTICLE AU - Jan Lötvall AU - Eric D. Bateman AU - Eugene R. Bleecker AU - William W. Busse AU - Ashley Woodcock AU - Richard Follows AU - Jessica Lim AU - Sally Stone AU - Loretta Jacques AU - Brett Haumann TI - 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids AID - 10.1183/09031936.00121411 DP - 2012 Sep 01 TA - European Respiratory Journal PG - 570--579 VI - 40 IP - 3 4099 - http://erj.ersjournals.com/content/40/3/570.short 4100 - http://erj.ersjournals.com/content/40/3/570.full SO - Eur Respir J2012 Sep 01; 40 AB - Current guidelines recommend adding a long-acting inhaled β2-agonist (LABA) to inhaled corticosteroids (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. The study involved a 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 yrs symptomatic on current ICS therapy. The primary end-point was trough (24 h post-dose) forced expiratory volume in 1 s (FEV1); secondary end-points were 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.