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

Abstract

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 firstline maintenance therapy in symptomatic patients by using short-acting β2-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 β2-agonists alone were treated with FP (88 μg [2 puffs of 44 μg] 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 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