Fluticasone propionate versus zafirlukast: effect in patients previously receiving inhaled corticosteroid therapy

Background: The use of inhaled corticosteroids compared with leukotriene mo difying drugs in the treatment of persistent asthma has not been extensivel y studied. Objective: To compare the efficacy and safety of a low dose of fluticasone propionate (FP) and zafirlukast in patients previously maintained on inhale d corticosteroids. Methods: Patients (greater than or equal to 12 years old; FEV1 = 60% to 85% of predicted) with persistent asthma who were previously treated with low doses of triamcinolone acetonide (TAA) 400 to 800 mug/day or beclomethasone dipropionate (BDP) 168 to 336 mug/day were randomized to treatment with FP aerosol 88 mug BID (FP, n = 221) or zafirlukast 20 mg BID (n = 216) over 6 weeks. Results: Treatment with FP significantly increased the mean change at endpo int (the last post-baseline observation) in FEV1 (0.22L versus 0.03L, P < . 001), morning PEF (17.8 versus 3.1 L/min, P = .004), evening PEF (16.7 vers us 2.6 L/min, P = .002), the percentage of symptom-free days (16.2 versus 7 .1%, P = .007), and the percentage of rescue-free days (23.4 versus 9.3%, P < .001), and significantly decreased rescue albuterol use (-0.66 puffs/day versus an increase of 0.27 puffs/day, P < .001) and combined symptom score s (-0.13 versus an increase of 0.08, P < .001) compared with zafirlukast. T reatment with FP maintained the percentage of awakening-free nights (-1.0 /- 1.0); in contrast, treatment with zafirlukast reduced the percentage of awakening-free nights (-9.0 +/- 1.6, P < .001). A clinically meaningful dif ference (change of <greater than or equal to>0.5; P < .001) was observed be tween FP and zafirlukast in the Asthma Quality of Life Questionnaire (AQLQ) global score and for each domain score except activity limitation (change of 0.3, P < .001). Significantly more patients in the zafirlukast group exp erienced an asthma exacerbation (n = 14) compared with FP-treated patients (n = 5, P = .035). Patients in the zafirlukast group were significantly mor e likely to be withdrawn due to lack of efficacy (P < .001). Conclusion: Switching patients from low doses of inhaled corticosteroids to a lower total microgram dose of FP improves pulmonary function, asthma sym ptoms, and quality of life, while switching to the lenkotriene receptor ant agonist zafirlukast may result in worsening of asthma control. This was ind icated by the significant number of zafirlukast-treated patients who were d ropped from the study due to lack of efficacy within 6 weeks of discontinui ng inhaled corticosteroids.