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fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P 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.