A comparison of short-term treatment with inhaled fluticasone propionate and zafirlukast for patients with persistent asthma

PURPOSE: To compare the short-term efficacy and safety of low-dose fluticas one propionate with that of oral zafirlukast therapy for patients previousl y treated with beta-2-agonists alone, and to evaluate the potential therape utic benefit of switching front zafirlukast to a low-dose inhaled corticost eroid. SUBJECTS AND METHODS: This study consisted of a 4-week randomized, double-b lind treatment period followed by a 4-week open-label period. Two hundred n inety-four patients greater than or equal to 12 years old with asthma previ ously uncontrolled with beta-2-agonists alone were randomly assigned to tre atment with low-dose inhaled fluticasone (88 mug twice daily) or oral zafir lukast (20 mg twice daily). After 4 weeks, all patients discontinued their double-blind therapy and received open-label fluticasone (88 mug twice dail y). Outcomes included pulmonary function, asthma symptoms, albuterol use, a sthma exacerbations, and adverse events. RESULTS: During the double-blind treatment period, fluticasone patients had significantly greater improvements in morning peak flow (29.3 L/min vs. 18 .3 L/min), percentage of symptom-free days (19.8% vs. 11.6%), and daily alb uterol use (-1.8 puffs per day vs. -1.1 puffs per day) compared with zafirl ukast patients (P less than or equal to0.025, each comparison). During the open-label treatment period, patients switched from zafirlukast to fluticas one experienced additional improvements in morning peak flow (17.2 L/min), evening peak flow (13.6 L/min), and FEV, (0.11 liter) and daily albuterol u se (-0.9 puffs daily) compared with values obtained at the end of the doubl e-blind treatment period (P less than or equal to0.001, each comparison). CONCLUSION: Low-dose fluticasone was more effective than zafirlukast in imp roving pulmonary function and symptoms in patients with persistent asthma. In addition, switching patients from zafirlukast to fluticasone further imp roved clinical outcomes. (C) 2001 by Excerpta Medica, Inc.