Low-dose inhaled fluticasone propionate versus oral zafirlukast in the treatment of persistent asthma

• Published in: Journal of allergy and clinical immunology Vol. 105; no. 6; pp. 1123 - 1129
• Main Authors: Bleecker, Eugene R., Welch, Michael J., Weinstein, Steven F., Kalberg, Christopher, Johnson, Marty, Edwards, Lisa, Rickard, Kathleen A.
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.06.2000; Elsevier
• Subjects: Administration, Inhalation; Administration, Oral; Adult; Aged; Androstadienes - administration & dosage; Androstadienes - pharmacokinetics; Anti-Asthmatic Agents - administration & dosage; asthma; Asthma - drug therapy; Biological and medical sciences; Child; Dose-Response Relationship, Drug; Female; Fluticasone; Fluticasone propionate; Forced Expiratory Volume; Humans; inhaled cortico-steroids; leukotriene modifiers; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Respiratory system; Therapeutic Equivalency; Tosyl Compounds - administration & dosage; Tosyl Compounds - pharmacokinetics; zafirlukast; PEF; leukotriene modifiers; asthma; FP; BID; inhaled cortico-steroids; zafirlukast; Fluticasone propionate; Human; Corticosteroid; Respiratory disease; Arachidonic acid derivatives; Zafirlukast; Antiinflammatory agent; Oral administration; Systemic route; Fluticasone; Antiasthma agent; Route of administration; Posology; Asthma; Inhalation; Leukotriene; Local administration; Chemotherapy; Treatment; Obstructive pulmonary disease; Antagonist; Comparative study; Biological receptor
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1067/mai.2000.106043

Background: Few studies have compared the efficacy of inhaled corticosteroids and leukotriene modifiers for the treatment of persistent asthma. Objective: Our purpose was to compare the efficacy of a low dose of inhaled fluticasone propionate (FP) with that of oral zafirlukast in the treatment of persistent asthma previously treated with short-acting β 2-agonists alone. Methods: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 451 patients aged 12 years and older with asthma who were symptomatic on short-acting β 2-agonists alone. After an 8- to 14-day run-in period, patients were randomized to treatment with FP 88 μg twice daily or zafirlukast 20 mg twice daily. Results: Treatment with FP was more effective than treatment with zafirlukast in increasing morning FEV 1 (by 0.42 L vs 0.20 L over baseline, P < .001), morning peak expiratory flow (by 49.94 L/min vs 11.68 L/min over baseline, P < .001), and evening PEF (by 38.91 L/min vs 10.50 L/min over baseline, P < .001). Statistically significant differences between the two treatments in FEV 1 were noted after the first observation (week 4) and in morning and evening peak expiratory flow by week 2. Mean change in percentage of symptom-free days was greater with FP than with zafirlukast (28.5% of days vs 15.6% of days, P < .001) and FP significantly increased the percentage of rescue-free days by 40.4% of days compared with 24.2% of days with zafirlukast ( P < .001). Treatment with FP significantly reduced albuterol use by 2.39 puffs per day compared with 1.45 puffs per day ( P < .001) and increased the percentage of nights with no awakenings by 21.2% of nights compared with 8.0% of nights with zafirlukast ( P < .001). Conclusion: The clinical effectiveness of a low dose of FP as first-line therapy in patients with persistent asthma who are symptomatic on β 2-agonists alone is superior to that of zafirlukast. (J Allergy Clin Immunol 2000;105:1123-9.)