title: Efficacy and safety of low-dose fluticasone propionate compared with zafirlukast in patients with persistent asthma.
abstract: 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 Fewer fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P 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.
authors.affiliation: St. John's Medical Research Group, 1900 South National Avenue, Suite 2690, Springfield, MO 65804, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Brabson
authors.forename: Dennis
authors.initials: D
authors.lastname: Clifford
authors.forename: Edward
authors.initials: E
authors.lastname: Kerwin
authors.forename: Gordon
authors.initials: G
authors.lastname: Raphael
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Pepsin
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Edwards
authors.forename: Sharon
authors.initials: S
authors.lastname: Srebro
authors.forename: Kathleen
authors.initials: K
authors.lastname: Rickard
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007211:Indoles; D008297:Male; D048448:Phenylcarbamates; D012129:Respiratory Function Tests; D013449:Sulfonamides; D014105:Tosyl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D007211:Indoles; D048448:Phenylcarbamates; D013449:Sulfonamides; D014105:Tosyl Compounds; D000068298:Fluticasone; C062735:zafirlukast