Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma.
OBJECTIVE
Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta(2) agonist) is a once-daily therapy for asthma and chronic obstructive pulmonary disease. This 12-week phase III study compared the efficacy and safety of once-daily (evening dosing) FF/VI 100/25 mcg versus FF 100 mcg (primary objective) and FF/VI 100/25 mcg versus FF/VI 200/25 mcg (descriptive comparison only) in patients (n = 1039) ≥12 years with moderate-to-severe persistent asthma.


METHODS
The primary end point was weighted mean (wm) 0-24-h serial forced expiratory volume in 1 s (FEV(1)) at week 12. Secondary end points (change from baseline) were trough FEV(1) and the proportion (%) of rescue-free 24-h periods (both powered), the proportion (%) of symptom-free 24-h periods, and morning and evening peak expiratory flow (PEF). Safety data (adverse events, AEs) were collected throughout.


RESULTS
Compared with FF 100 mcg, FF/VI 100/25 mcg significantly improved wmFEV(1) (p < 0.001), trough FEV(1) (p = 0.014), % rescue-free (p < 0.001), % symptom-free (p = 0.002) 24-h periods, and morning and evening PEF (p < 0.001). FF/VI 200/25 mcg produced small numerical improvements versus FF/VI 100/25 mcg for all end points. Incidence of AEs was similar across groups.


CONCLUSIONS
FF/VI 100/25 mcg resulted in significant improvements in all primary and secondary end points versus FF 100 mcg. Numerical improvements occurred with FF/VI 200/25 mcg versus FF/VI 100/25 mcg. All treatments were well tolerated.
a Division of Immunology and Allergy , University of Cincinnati and Bernstein Clinical Research Center , Cincinnati , OH , USA .
David I
DI
Bernstein
b Department of Medicine , University of Cape Town , Cape Town , South Africa .
Eric D
ED
Bateman
c Institute of Inflammation and Repair, University of Manchester , Manchester , UK .
Ashley
A
Woodcock
d Respiratory Medicines Development Center, GSK , Research Triangle Park , NC , USA .
William T
WT
Toler
e GSK Business Unit, PAREXEL , Research Triangle Park , NC , USA .
Richard
R
Forth
f Respiratory Medicines Development Centre, GSK , London , UK , and.
Loretta
L
Jacques
f Respiratory Medicines Development Centre, GSK , London , UK , and.
Carol
C
Nunn
g Michael G. DeGroote School of Medicine , Hamilton , ON , Canada.
Paul M
PM
O'Byrne
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001592:Benzyl Alcohols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002722:Chlorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D044469:Racial Groups; D012720:Severity of Illness Index; D055815:Young Adult
D000730:Androstadienes; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C550468:vilanterol; C523187:fluticasone furoate
Efficacy; inhaled corticosteroid; long-acting beta-agonist; lung function; safety