PT  - JOURNAL ARTICLE
AU  - J. Lötvall
AU  - E.D. Bateman
AU  - E.R. Bleecker
AU  - W.W. Busse
AU  - A. Woodcock
AU  - R. Follows
AU  - J. Lim
AU  - S. Stone
AU  - L. Jacques
AU  - B. Haumann
TI  - 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with ICSs
AID  - 10.1183/09031936.00121411
DP  - 2012 Jan 01
TA  - European Respiratory Journal
PG  - erj01214-2011
4099  - http://erj.ersjournals.com/content/early/2012/02/22/09031936.00121411.short
4100  - http://erj.ersjournals.com/content/early/2012/02/22/09031936.00121411.full
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.