Low-dose inhaled fluticasone propionate versus oral zafirlukast in the treatment of persistent asthma

J Allergy Clin Immunol. 2000 Jun;105(6 Pt 1):1123-9. doi: 10.1067/mai.2000.106043.


Background: Few studies have compared the efficacy of inhaled corticosteroids and leukotriene modifiers for the treatment of persistent asthma.

Objective: Our purpose was to compare the efficacy of a low dose of inhaled fluticasone propionate (FP) with that of oral zafirlukast in the treatment of persistent asthma previously treated with short-acting beta(2)-agonists alone.

Methods: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 451 patients aged 12 years and older with asthma who were symptomatic on short-acting beta(2)-agonists alone. After an 8- to 14-day run-in period, patients were randomized to treatment with FP 88 microg twice daily or zafirlukast 20 mg twice daily.

Results: Treatment with FP was more effective than treatment with zafirlukast in increasing morning FEV(1) (by 0.42 L vs 0.20 L over baseline, P <.001), morning peak expiratory flow (by 49.94 L/min vs 11.68 L/min over baseline, P <. 001), and evening PEF (by 38.91 L/min vs 10.50 L/min over baseline, P <.001). Statistically significant differences between the two treatments in FEV(1) were noted after the first observation (week 4) and in morning and evening peak expiratory flow by week 2. Mean change in percentage of symptom-free days was greater with FP than with zafirlukast (28.5% of days vs 15.6% of days, P <.001) and FP significantly increased the percentage of rescue-free days by 40.4% of days compared with 24.2% of days with zafirlukast (P <.001). Treatment with FP significantly reduced albuterol use by 2.39 puffs per day compared with 1.45 puffs per day (P <.001) and increased the percentage of nights with no awakenings by 21.2% of nights compared with 8.0% of nights with zafirlukast (P <.001).

Conclusion: The clinical effectiveness of a low dose of FP as first-line therapy in patients with persistent asthma who are symptomatic on beta(2)-agonists alone is superior to that of zafirlukast.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Administration, Oral
  • Adult
  • Aged
  • Androstadienes / administration & dosage*
  • Androstadienes / pharmacokinetics*
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / drug therapy*
  • Child
  • Dose-Response Relationship, Drug
  • Female
  • Fluticasone
  • Forced Expiratory Volume
  • Humans
  • Indoles
  • Male
  • Middle Aged
  • Phenylcarbamates
  • Sulfonamides
  • Therapeutic Equivalency
  • Tosyl Compounds / administration & dosage*
  • Tosyl Compounds / pharmacokinetics*


  • Androstadienes
  • Anti-Asthmatic Agents
  • Indoles
  • Phenylcarbamates
  • Sulfonamides
  • Tosyl Compounds
  • Fluticasone
  • zafirlukast