Fluticasone Alone or in Combination With Salmeterol vs Triamcinolone in Asthma

Objectives To compare the efficacies of medium-dose fluticasone propionate (FP), medium-dose triamcinolone acetonide (TAA), and combined low-dose FP plus salmeterol (SL). Design Randomized, double-blind, triple-dummy, multicenter, 12-week clinical trial. Setting Allergy/respiratory care clinics. Patients Six hundred eighty patients with asthma previously uncontrolled with low-dose inhaled corticosteroids. Interventions FP, 220 μg bid; TAA, 600 μg bid; or FP, 88 μg plus SL, 42 μg bid. Measurements and results Outcome measures included FEV 1 , peak expiratory flow (PEF), supplemental albuterol use, nighttime awakenings, asthma symptoms, and physician global assessment. Compared with TAA, 600 μg bid, treatment with FP 220, μg bid, significantly increased FEV 1 , morning and evening PEF, and percent symptom-free days, and significantly reduced rescue albuterol use, number of nighttime awakenings, and overall asthma symptom scores (p ≤ 0.035). Improvements with low-dose FP, 88 μg, plus SL, 42μ g bid, were significantly (p ≤ 0.004) greater than TAA, 600 μg bid, in all the aforementioned efficacy measures as well as percent of rescue-free days. Combined low-dose FP, 88 μg, plus SL, 42 μg bid, also significantly increased FEV 1 and percent of rescue-free days, and significantly reduced albuterol use compared with medium-dose FP, 220 μg bid (p ≤ 0.018). At endpoint, both FP, 220μ g bid, and FP, 88 μg, plus SL, 42 μg bid, significantly increased FEV 1 by 0.48 L and 0.58 L, respectively, compared with 0.34 L with TAA, 600 μg bid. Conclusion In patients who are symptomatic while taking low-dose inhaled corticosteroids, medium-dose FP (440 μg/d) and combination treatment with low-dose FP (176 μg/d) plus SL (84 μg/d) are both more effective than medium-dose TAA (1200 μg/d) in improving pulmonary function and asthma symptom control.