title: 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids.
abstract: Current guidelines recommend adding a long-acting inhaled β(2)-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 (FEV(1)); secondary end-points were weighted mean FEV(1), peak expiratory flow (PEF), symptom-/rescue-free 24-h periods, and safety. A significant relationship was observed between VI dose and improvements in trough FEV(1) (p=0.037). Statistically significant increases in mean trough FEV(1), 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) FEV(1), 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.
authors.affiliation: Krefting Research Centre, University of Gothenburg, Box 424, SE 40530 Gothenburg, Sweden. jan.lotvall@gu.se
authors.forename: Jan
authors.initials: J
authors.lastname: Lötvall
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.forename: Richard
authors.initials: R
authors.lastname: Follows
authors.forename: Jessica
authors.initials: J
authors.lastname: Lim
authors.forename: Sally
authors.initials: S
authors.lastname: Stone
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.forename: Brett
authors.initials: B
authors.lastname: Haumann
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001592:Benzyl Alcohols / Q000627:therapeutic use*; D002722:Chlorobenzenes / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012129:Respiratory Function Tests; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; C550468:vilanterol