Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma

Asthma is a chronic disease characterized by inflammation and bronchoconstriction. Medications that are able to effectively treat both components are advantageous. To compare the efficacy of an inhaled corticosteroid and a long-acting β 2-agonist combination product with a leukotriene antagonist for initial maintenance therapy in patients who were symptomatic while receiving short-acting β 2-agonists alone. A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 432 patients 15 years of age and older with persistent asthma who were symptomatic on short-acting β 2-agonists alone. Fluticasone propionate 100 μg and salmeterol 50 μg combination product (FSC) twice daily or montelukast 10 mg once daily was administered. At endpoint, compared with montelukast, FSC significantly increased morning predose forced expiratory volume in 1 second (0.61 ± 0.03L vs 0.32 ± 0.03L), morning peak expiratory flow rate (peak expiratory flow rate; 81.4 ± 5.9 L/minute vs 41.9 ± 4.8 L/minute), evening peak expiratory flow rate (64.6 ± 5.3 L/minute vs 38.8 ± 4.7 L/minute), the percentage of symptom-free days (40.3 ± 2.9% vs 27.0 ± 2.7%), the percentage of rescue-free days (53.4 ± 2.8% vs 26.7 ± 2.5%), and the percentage of nights with no awakenings (29.8 ± 2.5% vs 19.6 ± 2.1%) ( P ≤ 0.011, all comparisons). At endpoint, FSC significantly reduced asthma symptom scores (−1.0 ± 0.1 vs −0.7 ± 0.1) and rescue albuterol use (−3.6 ± 0.2 puffs/day vs −2.2 ± 0.2 puffs/day) compared with montelukast ( P < 0.001). At endpoint, patients treated with FSC also had a significantly greater improvement in quality of life scores and were more satisfied with their treatment compared with montelukast-treated patients ( P ≤ 0.001). Both treatments were well tolerated. Initial maintenance therapy with FSC provides greater improvement in asthma control and patient satisfaction than montelukast.