Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids

Int J Clin Pract. 2005 Jul;59(7):754-9. doi: 10.1111/j.1368-5031.2005.00474.x.

Abstract

A randomised, open-label, multicentre study compared the efficacy and tolerability of salmeterol 25 microg/fluticasone propionate 125 microg (two puffs, twice daily) delivered via a hydrofluoroalkane metered-dose inhaler (HFA-MDI) and salmeterol 50microg/fluticasone propionate 250 microg (one puff, twice daily) delivered via a Diskus inhaler in Chinese patients with moderate asthma uncontrolled with inhaled corticosteroids (ICSs). Morning peak expiratory flow (PEF) was the primary efficacy endpoint. Secondary endpoints included evening PEF, forced expiratory volume in 1 s, day and night symptom scores, rescue medication and patient self-evaluation of efficacy. Safety was assessed according to adverse events recorded. Both treatments were equipotent and significantly improved morning PEF (HFA-MDI 40 l/min; Diskus 42 l/min; p < 0.05) and all secondary endpoints (p < 0.05) from baseline, over 1-4 weeks. Similarly, both treatments were well tolerated. Salmeterol/fluticasone propionate delivered via an HFA-MDI or Diskus inhaler provides a choice of efficacious delivery systems in Chinese patients whose asthma is poorly controlled on ICSs alone.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage
  • Adult
  • Aerosol Propellants
  • Aged
  • Albuterol / administration & dosage
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives*
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / adverse effects
  • Drug Therapy, Combination
  • Female
  • Fluticasone
  • Humans
  • Male
  • Metered Dose Inhalers*
  • Middle Aged
  • Peak Expiratory Flow Rate
  • Salmeterol Xinafoate
  • Treatment Outcome

Substances

  • Adrenal Cortex Hormones
  • Aerosol Propellants
  • Androstadienes
  • Bronchodilator Agents
  • Salmeterol Xinafoate
  • Fluticasone
  • Albuterol