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

OBJECTIVE The objective of our study was to compare the efficacy and safety of fluticasone propionate tan 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 mug 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 beta (2)-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. RE SU LTS 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 beta (2)-agonists alone.