Fluticasone propionate compared with zafirlukast in controlling persistentasthma - 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 dai ly), 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, advers e events, and clinically significant laboratory test results. RE SU LTS Aft er 12 weeks of treatment, patients taking fluticasone propionate experience d significantly greater improvements in all clinical parameters (symptom sc ores, percentages of symptom-free and albuterol-free days, albuterol use, a nd nighttime awakenings) compared with patients taking zafirlukast (P < .05 ) or placebo (P < .05). Treatment with fluticasone propionate resulted in s ignificantly greater improvements in pulmonary function compared with zafir lukast (P < .05) or placebo (P < .05), Fewer fluticasone propionate patient s (4%) had an exacerbation requiring oral corticosteroids compared with tho se taking zafirlukast (12%) or placebo (10%). CONCLUSIONS Inhaled fluticasone propionate is more effective than zafirluka st in controlling asthma symptoms, improving pulmonary function, and improv ing quality of life for patients who are symptomatic with tile use of short -acting beta (2)-agonists alone.