EFFICACY AND SAFETY OF LOW-DOSE FLUTICASONE PROPIONATE COMPARED WITH ZAFIRLUKAST IN PATIENTS WITH PERSISTENT ASTHMA

Allen Adinoff

Brabson JH, Clifford D, Kerwin E, et al. Am J Med. 2002;113:15–21

Purpose of the Study.

The study was designed 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 β₂-agonists.

Patient Population and Methods.

A total of 440 patients (≥12 years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate or triamcinolone acetonide) and short-acting β₂-agonists were included in this randomized, double-blind study. After an 8-day run-in period, patients were treated with fluticasone (88 μg) or zafirlukast (20 mg) twice daily for 6 weeks. Outcome measures included pulmonary function (forced expiratory volume in 1 second [FEV₁], peak expiratory flow [PEF]), albuterol use, asthma symptoms, withdrawals attributable to lack of efficacy, and asthma exacerbations.

Results.

Patients treated with fluticasone (n = 224) experienced greater mean increases in FEV₁ (0.24 L vs 0.08 L; P < .001), morning PEF (30 L/min vs 6 L/min; P < .001), and evening PEF (23 L/min vs 5 L/min; P < .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 < .001), rescue-free days (23% vs 10%; P = .002), nights with uninterrupted sleep (<1% vs −5%; P = .006), and fewer asthma exacerbations (1% vs 6%; P = .005). Fewer fluticasone-treated patients were withdrawn because of a lack of efficacy (2% vs 13%; P < .001).

Conclusions.

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.

Reviewer’s Comments.

So the debate rages on. What’s different here is that the dose of fluticasone used was very low; only slightly greater than waving the inhaler over the patient’s head. On the other hand, we all see patients whose symptoms are extremely well-controlled with leukotriene receptor antagonists.

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