Short- and long-term effects of fluticasone furoate/vilanterol in exercising asthmatic adolescents: A randomized and open label trial

Basic Clin Pharmacol Toxicol. 2021 Nov;129(5):369-375. doi: 10.1111/bcpt.13640. Epub 2021 Aug 25.

Abstract

Purpose: Relvar® (fluticasone furoate [FF]/vilanterol [VI]) is a once-daily inhaler with bronchodilator effect lasting 24 h. Our aim was to investigate the short- and long-term effects of FF/VI on exercise-induced asthma (EIA) in adolescents.

Methods: Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. Following a positive exercise challenge test (ECT), 22/44 were allocated to a single administration of salbutamol (400 μg) and 22/44 to FF/VI (92/22 μg) in a double-blind method. Thirty-five subjects were reassessed by repeat ECT 30-60 days of FF/VI.

Results: Median FEV1 change post-ECT at baseline was -22.8% predicted (interquartile range [IQR] -26.1 and -18.0) for salbutamol and -21.0 (IQR -30.7 and -16.8) for FF/VI. Following bronchodilator, FEV1 improved similarly in both groups. Repeat ECT following 30-60 days of FF/VI resulted in negative ECT in 33/35 subjects; the median decrease in FEV1 of these 35 subjects was 22.6% predicted (IQR 29-18) before, and 4.6% predicted (IQR 8.7-2.5) after 30-60 days of FF/VI treatment (p < 0.0001).

Conclusions: FF/VI is effective in reversing EIA after 15 min in adolescents and in protecting EIA after 30-60 days in adolescents. Larger studies are needed to assess the effect of FF/VI on EIA.

Keywords: Relvar; exercise challenge test; exercise-induced asthma; exercise-induced bronchoconstriction; fluticasone furoate (FF)/vilanterol (VI); salbutamol.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Albuterol / administration & dosage*
  • Albuterol / pharmacology
  • Androstadienes / administration & dosage*
  • Androstadienes / pharmacology
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Benzyl Alcohols / administration & dosage*
  • Benzyl Alcohols / pharmacology
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / pharmacology
  • Child
  • Chlorobenzenes / administration & dosage*
  • Chlorobenzenes / pharmacology
  • Double-Blind Method
  • Drug Combinations
  • Exercise Test
  • Female
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Nebulizers and Vaporizers
  • Prospective Studies
  • Time Factors
  • Treatment Outcome

Substances

  • Androstadienes
  • Benzyl Alcohols
  • Bronchodilator Agents
  • Chlorobenzenes
  • Drug Combinations
  • fluticasone furoate-vilanterol trifenatate
  • Albuterol