Randomised, double-blind, placebo-controlled, cross-over single dose study of the bronchodilator duration of action of combination fluticasone furoate/vilanterol inhaler in adult asthma.
Fluticasone furoate (FF)/vilanterol (VI) is a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease. The duration of bronchodilation beyond 24 h has not been determined previously.



Adults aged 18-65 (n = 32), with asthma and reversibility to salbutamol (≥15% and ≥200 mL increase in forced expiratory volume in 1 s [FEV1]) participated in a double-blind, placebo-controlled, crossover study. Patients were admitted to a clinical trials unit for 72 h, and inhaled, in random order, placebo or FF/VI 100/25 mcg via ELLIPTA dry powder inhaler on two occasions 7-14 days apart. FEV1was measured at baseline, 15 and 30 min, 1, 2, 4, 12, 24, 36, 48, 60, and 72 h. The differences in change in FEV1from baseline between treatments and corresponding two-sided 95% confidence intervals (CI) were calculated at each time point.



FF/VI produced a rapid onset of bronchodilation (adjusted mean difference in change from baseline in FEV1versus placebo at 15 min, 252 mL [95% CI 182-322]). Maximum bronchodilation was observed at 12 h (adjusted mean difference in the change from baseline in FEV1, 383 mL [95% CI 285-481]). Bronchodilation was maintained throughout the 72-h assessment period (adjusted mean difference in the change in FEV1from baseline at 72 h, 108 mL (95% CI 15-200]). FF/VI was well tolerated and no serious side effects were reported.



A single dose of FF/VI 100/25 mcg showed evidence of a 72-h bronchodilator duration of action in adults with asthma.
Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: Irene.Braithwaite@mrinz.ac.nz.
Irene
I
Braithwaite
Medical Research Institute of New Zealand, Wellington, New Zealand.
Mathew
M
Williams
Medical Research Institute of New Zealand, Wellington, New Zealand.
Sharon
S
Power
Medical Research Institute of New Zealand, Wellington, New Zealand.
Janine
J
Pilcher
Rehabilitation Teaching and Research Unit, University of Otago Wellington, Wellington, New Zealand.
Mark
M
Weatherall
Medicines Research Centre, GlaxoSmithKline Research and Development, Stevenage, UK.
Amanda
A
Baines
Synergy Clinical, Langley, UK.
Jackie
J
Moynihan
Medicines Research Centre, GlaxoSmithKline Research and Development, Stevenage, UK.
Rodger
R
Kempsford
Medical Research Institute of New Zealand, Wellington, New Zealand; Capital and Coast District Health Board, Wellington, New Zealand.
Richard
R
Beasley
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage* / Q000494:pharmacology; D000730:Androstadienes / Q000008:administration & dosage* / Q000494:pharmacology; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001592:Benzyl Alcohols / Q000008:administration & dosage* / Q000494:pharmacology; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002722:Chlorobenzenes / Q000008:administration & dosage* / Q000494:pharmacology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D010919:Placebos; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; D010919:Placebos; C000611924:fluticasone furoate-vilanterol trifenatate; D000420:Albuterol
Asthma; Bronchodilation; Duration of action; Fluticasone furoate/vilanterol; Randomised placebo-controlled trial