To compare the efficacy and safety of fluticasone propionate and zafirlukast in patients
with relatively stable persistent asthma who were previously treated with inhaled
corticosteroids and short-acting beta(2)-agonists.A total of 440 patients (> or =12
years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate
or triamcinolone acetonide) and short-acting beta(2)-agonists were included in this
randomized double-blind study. After an 8-day run-in period, patients were treated
with fluticasone (88 microg) or zafirlukast (20 mg) twice daily for 6 weeks. Outcome
measures included pulmonary function (forced expiratory volume in 1 second [FEV(1)],
peak expiratory flow [peak flow]), albuterol use, asthma symptoms, withdrawals due
to lack of efficacy, and asthma exacerbations. Patients treated with fluticasone (n
= 224) experienced greater mean increases in FEV(1) (0.24 L vs. 0.08 L, P <0.001),
morning peak flow (30 L/min vs. 6 L/min, P <0.001), and evening peak flow (23 L/min
vs. 5 L/min, P <0.001) during the study than did those treated with zafirlukast (n
= 216). Fluticasone-treated patients had significantly greater increases in the mean
percentages of symptom-free days (22% vs. 8%, P <0.001), rescue-free days (23% vs.
10%, P = 0.002), nights with uninterrupted sleep (<1% vs. -5%, P = 0.006), and fewer
asthma exacerbations (1% vs. 6%, P = 0.005). Fewer fluticasone-treated patients were
withdrawn due to lack of efficacy (2% vs. 13%, P <0.001).Inhaled fluticasone was more
effective than zafirlukast in maintaining or improving asthma control in patients
with relatively stable asthma who were switched from low-dose inhaled corticosteroids.