Control of mild to moderate asthma over 1-year with the combination of salmeterol and fluticasone propionate

Respir Med. 2006 Jan;100(1):2-10. doi: 10.1016/j.rmed.2005.09.006. Epub 2005 Oct 21.


Objective: The aim of this study was to assess asthma control using salmeterol plus fluticasone propionate (FP) in combination (SFC) versus salmeterol or FP as monotherapy in patients with mild to moderate asthma.

Methods: In this randomised, double-blind, parallel-group study, 322 symptomatic patients were recruited, of which 282 were randomised to receive either salmeterol (50 microg), FP (250 microg), or SFC (50 microg/250 microg), via a single Diskus inhaler twice daily for 12 months. Outcome variables included the number of patients requiring an increase in study medication and the number experiencing 2 exacerbations during the 12-month treatment period. Airway hyper-responsiveness (AHR) and lung function tests were performed at clinic visits. Peak expiratory flow, rescue medication use, symptom scores and adverse events were recorded in diary cards.

Results: Fewer patients required an increase in study medication with SFC (10.5%) than with either FP (34.8%) or salmeterol (61.1%) (P<0.001). Significantly fewer patients experienced 2 exacerbations with SFC (4.2%), compared with FP (17.4%; P<0.01) or salmeterol (40%; P<0.001). SFC improved AHR to a significantly greater extent than FP (methacholine PC20=1.8 mg/ml vs. 1.1 mg/ml; P<0.05) or salmeterol (methacholine PC20=1.8 mg/ml vs. 0.7 mg/ml; P<0.001).

Conclusions: The protection against exacerbations may be attributed to better control of inflammation, AHR and lung function parameters achieved with salmeterol and FP in combination, compared with either treatment alone.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Albuterol / administration & dosage
  • Albuterol / analogs & derivatives*
  • Androstadienes / administration & dosage*
  • Asthma / drug therapy*
  • Bronchodilator Agents / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluticasone
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Middle Aged
  • Peak Expiratory Flow Rate / drug effects
  • Salmeterol Xinafoate
  • Vital Capacity / drug effects


  • Androstadienes
  • Bronchodilator Agents
  • Salmeterol Xinafoate
  • Fluticasone
  • Albuterol