Long-term treatment with fluticasone propionate/salmeterol via Diskus improves asthma control versus fluticasone propionate alone

Allergy Asthma Proc. 2011 Mar-Apr;32(2):127-36. doi: 10.2500/aap.2011.32.3426. Epub 2010 Dec 28.


This 52-week study was designed to assess the safety and efficacy of fluticasone propionate/salmeterol combination (FSC) 250/50 micrograms versus fluticasone propionate (FP) 250 micrograms in subjects with persistent asthma symptomatic on open-label FP 100 micrograms. The primary objective of this study was to show that FSC 250/50 micrograms was superior to FP 250 micrograms at increasing pulmonary function as measured by forced expiratory volume in 1 second over a 52-week treatment period. A secondary objective was to compare the rate of asthma attacks defined as (1) a sustained 2-day decrease in morning peak expiratory flow or increase in albuterol use for 2 consecutive days, (2) an asthma exacerbation requiring systemic corticosteroids, or (3) an unscheduled clinic or hospital visit for acute asthma symptoms. Three hundred six subjects received FSC 250/50 micrograms and 315 subjects received FP 250 micrograms. Both treatments were administered twice daily. Treatment with FSC 250/50 micrograms resulted in a significant improvement in lung function compared with FP 250 micrograms (p < 0.001). Additionally, treatment with FSC 250/50 micrograms resulted in a reduction in the rate of exacerbations of asthma (i.e., requiring systemic corticosteroids or unscheduled urgent care intervention) compared with FP 250 micrograms (0.170 versus 0.273, respectively; p = 0.017). There was no differentiation between treatments for less severe attacks of asthma. FSC 250/50 micrograms showed consistently greater improvement in lung function, symptom control, and decreased albuterol use. In addition, FSC 250/50 micrograms-treated subjects experienced fewer severe asthma exacerbations than subjects treated with FP 250 micrograms.

Publication types

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

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / pharmacology
  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Albuterol / analogs & derivatives*
  • Albuterol / pharmacology
  • Albuterol / therapeutic use
  • Androstadienes / pharmacology*
  • Androstadienes / therapeutic use
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Child
  • Drug Combinations
  • Female
  • Fluticasone
  • Fluticasone-Salmeterol Drug Combination
  • Forced Expiratory Volume / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Salmeterol Xinafoate
  • Time Factors
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Androstadienes
  • Drug Combinations
  • Fluticasone-Salmeterol Drug Combination
  • Salmeterol Xinafoate
  • Fluticasone
  • Albuterol