Fluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast

Background: Asthma is a disease of chronic inflammation and bronchoconstric tion. Inhaled corticosteroids (ICSs) provide important anti-inflammatory tr eatment but may not provide optimal control of asthma when taken alone. Two therapeutic alternatives for enhanced asthma control are to substitute the combination of fluticasone propionate (FP) and salmeterol (FP/Salm Combo) through the Diskus inhaler or to add montelukast to existing ICS therapy Objective: We compared the efficacy and safety of FP/Salm Combo through the Diskus inhaler versus montelukast added to FP (FP + montelukust) in patien ts whose symptoms were suboptimally controlled with ICS therapy. Methods: We performed a multicenter, double-blind, double-dummy, parallel-g roup, 12-week study in 447 patients dth asthma who were symptomatic at base line while receiving low-dose FP, Patients were treated for 12 weeks,vith o ne of the following: (1) combination of FP 100 mug plus salmeterol 50 mug t wice daily through the Diskus inhaler, or (2) EP 100 mug twice daily throug h the Diskus inhaler plus oral montelukast 10 mg once daily, Results: FP/Salm Combo treatment provided better overall asthma control tha n FP + montelukast with significantly greater improvements in morning peak expiratory flow (+24.9 L/min vs +13.0 L/min, P < .001), evening peak expira tory flew (+18.9 L/min vs +9.6 L/min, P < .001), and forced expiratory volu me in 1 second (+0.34 L vs +0.20 L, P < .001), as well as a change in the p ercentage of days with no albuterol use (+26.3 % vs +19.1%, P = .032) and t he shortness of breath symptom score (-0.56 vs -0.40, P = .017). The groups had comparable improvements in chest tightness, wheeze, and overall sympto m scores. Asthma exacerbation rates were significantly lower (P = .031) in the FP/Salm Combo group (4 patients, 2%) than in the FP + montelukast group (13 patients, 6%). Adverse event profiles were comparable. Conclusion: Symptomatic patients on low-dose ICS therapy had significantly greater improvement in asthma control when switched to the FP/Salm Combo th an when montelukast was added to ICS therapy.