Fluticasone propionate compared with zafirlukast in controlling persistent asthma: a randomized double-blind, placebo-controlled trial

J Fam Pract. 2001 Jul;50(7):595-602.


Objective: The objective of our study was to compare the efficacy and safety of fluticasone propionate (an inhaled corticosteroid) with zafirlukast (a leukotriene modifier) for persistent asthma.

Study design: In this randomized placebo-controlled, parallel-group, double-blind, double-dummy trial, patients underwent an 8- to 14-day run-in period followed by 12 weeks of treatment with inhaled fluticasone propionate (88 mg twice daily by metered-dose inhaler), oral zafirlukast (20 mg twice daily), or placebo.

Population: We included a total of 338 persistent asthma patients, 12 years of age or older, using short-acting b2-agonists alone.

Outcomes: measured Efficacy outcomes included changes in pulmonary function, asthma symptoms, rescue albuterol use, nighttime awakenings due to asthma, and quality of life. Safety outcomes included asthma exacerbations, adverse events, and clinically significant laboratory test results.

Results: After 12 weeks of treatment, patients taking fluticasone propionate experienced significantly greater improvements in all clinical parameters (symptom scores, percentages of symptom-free and albuterol-free days, albuterol use, and nighttime awakenings) compared with patients taking zafirlukast (P <.05) or placebo (P <.05). Treatment with fluticasone propionate resulted in significantly greater improvements in pulmonary function compared with zafirlukast (P <.05) or placebo (P <.05). Fewer fluticasone propionate patients (4%) had an exacerbation requiring oral corticosteroids compared with those taking zafirlukast (12%) or placebo (10%).

Conclusions: Inhaled fluticasone propionate is more effective than zafirlukast in controlling asthma symptoms, improving pulmonary function, and improving quality of life for patients who are symptomatic with the use of short-acting b2-agonists alone.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Androstadienes / administration & dosage
  • Androstadienes / therapeutic use*
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / therapeutic use*
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Asthma / drug therapy*
  • Child
  • Double-Blind Method
  • Female
  • Fluticasone
  • Humans
  • Indoles
  • Leukotriene Antagonists / administration & dosage
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Phenylcarbamates
  • Respiratory Function Tests
  • Sulfonamides
  • Tosyl Compounds / administration & dosage
  • Tosyl Compounds / therapeutic use*


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