Purpose of the Study. To compare the short-term efficacy and safety of low-dose fluticasone propionate with that of oral zafirlukast therapy for patients previously treated with β2-agonists alone, and to evaluate the potential therapeutic benefit of switching from zafirlukast to a low-dose inhaled corticosteroid.
Subjects and Methods. This study consisted of a 4-week randomized, double-blind treatment period followed by a 4-week open-label period. Two hundred ninety-four patients ≥12 years old with asthma previously uncontrolled with β2-agonists alone were randomly assigned to treatment with low-dose inhaled fluticasone (88 μg twice daily) or oral zafirlukast (20 mg twice daily). After 4 weeks, all patients discontinued their double-blind therapy and received open-label fluticasone (88 μg twice daily). Outcomes included pulmonary function, asthma symptoms, albuterol use, asthma exacerbations, and adverse events.
Results. During the double-blind treatment period, fluticasone patients had significantly greater improvements in morning peak flow (29.3 L/min vs 18.3 L/min), percentage of symptom-free days (19.8% vs 11.6%), and daily albuterol use ( -1.8 puffs per day vs -1.1 puffs per day) compared with zafirlukast patients (P ≤ .025, each comparison). During the open-label treatment period, patients switched from zafirlukast to fluticasone experienced additional improvements in morning peak flow (17.2 L/min), evening peak flow (13.6 L/min), and forced expiratory volume in 1 second (FEV1) (0.11 liter) and daily albuterol use ( -0.9 puffs daily) compared with values obtained at the end of the double-blind treatment period (P ≤ .001, each comparison).
Conclusions. Low-dose fluticasone was more effective than zafirlukast in improving pulmonary function and symptoms in patients with persistent asthma. In addition, switching patients from zafirlukast to fluticasone further improved clinical outcomes.
Reviewer’s Comments. The emerging consensus is that inhaled corticosteroids, in general, are more effective monotherapy for asthma than are leukotriene receptor antagonists, at least in short-term studies. Certainly, however, many individual patients with mild persistent asthma will do very well taking only leukotriene receptor antagonists. In addition, long-term studies may suggest at least similar benefits due to improved compliance with oral medications.
- Copyright © 2002 by the American Academy of Pediatrics