Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in patients who are symptomatic on short-acting β₂-agonists alone

The objective of this study was to determine whether initial maintenance therapy for the treatment of inflammation and bronchoconstriction associated with persistent asthma is more effective with a combination product (100 μg of fluticasone propionate and 50 μg of salmeterol [FSC]) administered twice daily through the Diskus device (GlaxoWellcome, Research Triangle Park, NC) or with montelukast at 10 mg once daily. A 12-wk, randomized, double-blind, double-dummy, multicenter study was conducted with 423 patients 15 yr of age and older with asthma and who were symptomatic while receiving short-acting β₂-agonists alone. At end point, FSC resulted in significantly greater increases in morning predose FEV₁ (0.54 ± 0.03 vs. 0.27 ± 0.03 L), morning peak expiratory flow (PEF) (89.9 ± 6.7 vs. 34.2 ± 4.7 L/min), evening PEF (69.9 ± 5.8 vs. 31.1 ± 4.5 L/min), the percentage of symptom-free days (48.9 ± 2.9 vs. 21.7 ± 2.5%), the percentage of rescue-free days (53.0 ± 2.8 vs. 26.2 ± 2.5%), and the percentage of nights with no awakenings (23.0 ± 2.5 vs. 15.5 ± 2.4%) compared with montelukast (p ≤ 0.001, all comparisons). FSC significantly reduced asthma symptom scores (-1.0 ± 0.1 vs. -0.6 ± 0.1), rescue albuterol use (-3.3 ± 0.2 vs. -1.9 ± 0.2 puffs/d), and the number of exacerbations (0 vs. 11) compared with montelukast (p < 0.001). Both treatments were well tolerated. In summary, treatment of the two main components of asthma (inflammation and bronchoconstriction) with fluticasone propionate and salmeterol in a combination product was a more effective initial maintenance treatment strategy than treatment with montelukast, a single-mediator antagonist.