Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: A randomized clinical trial

Background: Both inhaled corticosteroids and leukotriene modifiers are used in the maintenance treatment of persistent asthma. Objective: The goal was to compare the efficacy and safety of low-dose fluticasone propionate (FP) and montelukast as first-line maintenance therapy in symptomatic patients by using short-acting beta (2)-agonists alone to treat persistent asthma. Methods: In this multicenter, randomized, double-blind, double-dummy, parallel-group study 533 patients (>15 years old) with persistent asthma who remained symptomatic while taking short-acting beta (2)-agonists alone were treated with FP (88 mug [2 puffs of 44 mug] twice daily) or montelukast (10 mg once daily) for 24 weeks. Results: Compared with treatment with montelukast, treatment with FP resulted in significantly greater improvements at endpoint in morning predose FEV1 (22.9% vs 14.5%, P < .001), forced midexpiratory flow (0.66 vs 0.41 L/sec, P < .001), forced vital capacity (0.42 vs 0.29 L, P = .002), morning peak expiratory flow (PEF) (68.5 vs 34.1 L/min, P < .001), and evening PEF (53.9 vs 28.7 L/min, P < .001). Similar improvements in PEF were observed in patients with milder asthma (>70%-80% predicted FEV1). At endpoint, FP was more effective than montelukast at decreasing rescue albuterol use (3.1 puffs/day vs 2.3 puffs/day, P < .001), asthma symptom scores (-0.85 [48.6% decrease] vs -0.60 [30.5%], P < .001), and night-time awakenings due to asthma (-0.64 awakenings/night [62% decrease] vs -0.48 awakenings/night [47.5%], P = .023), and FP increased the percentage of symptom-free days (32.0% vs 18.4% of days, P < .001) compared with montelukast. The adverse event and asthma exacerbation profiles for FP and montelukast were similar. Conclusions: Low-dose FP is more effective than montelukast as first-line maintenance therapy for patients with persistent asthma who are undertreated and remain symptomatic while taking short-acting (2)-agonists alone.