Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial

Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.


Background: A variety of different fixed-dose combinations of inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) are available for the treatment of asthma. The aim of this 24-week, open-label, multicenter, Phase IIIb randomized controlled trial was to evaluate the efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI; 100/25 or 200/25 μg) compared with twice-daily fixed combinations of ICS/LABA (fluticasone propionate/salmeterol [FP/S] and budesonide/formoterol [BUD/F]) as maintenance therapy in patients with uncontrolled asthma treated with ICS alone.

Methods: Adult patients with documented physician-diagnosed asthma ≥1 year with an Asthma Control Test (ACT) score ≥15 and < 20 were included. The primary study endpoint was change from baseline in ACT total score at Week 12.

Results: Overall, 423 patients were randomized to receive study medication in France and Germany. The least-squares mean change (standard error) in ACT total score at Week 12 was 3.6 units with FF/VI and 2.8 with usual ICS/LABA, giving a treatment difference of 0.8 (95% confidence interval 0.1, 1.5; p = 0.033). Non-inferiority of FF/VI to usual ICS/LABA was confirmed at Weeks 6, 18 and 24. The observed safety profile for FF/VI in this study was in line with previous experience with FF/VI.

Conclusions: These findings suggest that, in a tightly controlled randomized controlled trial setting, once-daily FF/VI provides similar asthma control over 24 weeks to usual, twice-daily ICS/LABA in patients with asthma that is uncontrolled on ICS alone. FF/VI was well tolerated.

Trial registration: ClinicalTrials.gov NCT02446418.

Keywords: Asthma; Fluticasone furoate/vilanterol; Inhaled corticosteroids; Long-acting β(2)-agonists.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Adrenergic beta-2 Receptor Agonists / administration & dosage*
  • Adrenergic beta-2 Receptor Agonists / adverse effects
  • Adult
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / adverse effects
  • Asthma / drug therapy*
  • Benzyl Alcohols / administration & dosage*
  • Benzyl Alcohols / adverse effects
  • Chlorobenzenes / administration & dosage*
  • Chlorobenzenes / adverse effects
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • France
  • Germany
  • Humans
  • Middle Aged
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Adrenergic beta-2 Receptor Agonists
  • Androstadienes
  • Anti-Asthmatic Agents
  • Benzyl Alcohols
  • Chlorobenzenes
  • Drug Combinations
  • fluticasone furoate-vilanterol trifenatate

Associated data

  • ClinicalTrials.gov/NCT02446418