Fluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: a randomized trial

Respir Med. 2015 Jan;109(1):44-53. doi: 10.1016/j.rmed.2014.10.012. Epub 2014 Oct 31.

Abstract

Background: This study investigated the efficacy and safety of the inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combination fluticasone furoate (FF)/vilanterol (VI) in Asian asthma patients.

Methods: A 12-week, double-blind, double-dummy, active-comparator, parallel-group, multicenter study. 309 Asian asthma patients (≥12 years, uncontrolled with high-strength ICS or mid-dose ICS/LABA) were randomized (1:1) and included in the intent-to-treat population; 155 received once-daily FF/VI 200/25 mcg and 154 received twice-daily fluticasone propionate (FP) 500 mcg. The primary endpoint was change from baseline in daily evening peak expiratory flow (PEF) averaged over 12 weeks. Secondary endpoints were mean change from baseline in % rescue-free 24-h periods, daily morning PEF, % symptom-free 24-h periods, and overall Asthma Quality of Life Questionnaire score. Safety assessments were performed.

Results: For change from baseline in daily evening PEF, the adjusted mean treatment difference for FF/VI versus FP of 28.5 L/min (95% confidence interval [CI]: 20.1, 36.9) was clinically and statistically significant (p < 0.001). For change from baseline in % rescue-free 24-h periods, the adjusted mean treatment difference (1.0%; 95% CI: -7.3, 9.2) was not statistically significant (p = 0.821). Statistical significance could not be inferred for the remaining endpoints due to the statistical hierarchy employed. Incidence of on-treatment adverse events was similar with FF/VI (26%; 3% treatment-related; n = 1 serious) and FP (27%; 3% treatment-related; n = 2 serious); none were fatal. No further safety concerns were identified.

Conclusions: FF/VI improved evening PEF over 12 weeks versus FP in Asian patients, with a similar safety profile. The results are generally consistent with a global study comparing the same treatments.

Trial registration: ClinicalTrials.gov NCT01498653.

Keywords: Active-control; Efficacy; Fluticasone propionate; Inhaled corticosteroid; Long-acting beta-agonist; Safety.

Publication types

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

MeSH terms

  • Adolescent
  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / adverse effects
  • Adrenergic beta-2 Receptor Agonists / therapeutic use*
  • Adult
  • Aged
  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Benzyl Alcohols / administration & dosage
  • Benzyl Alcohols / adverse effects
  • Benzyl Alcohols / therapeutic use*
  • Chlorobenzenes / administration & dosage
  • Chlorobenzenes / adverse effects
  • Chlorobenzenes / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Dry Powder Inhalers
  • Female
  • Forced Expiratory Volume / drug effects
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Peak Expiratory Flow Rate / drug effects
  • Treatment Outcome
  • Young Adult

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Androstadienes
  • Benzyl Alcohols
  • Chlorobenzenes
  • Drug Combinations
  • Glucocorticoids
  • vilanterol
  • fluticasone furoate

Associated data

  • ClinicalTrials.gov/NCT01498653