The addition of salmeterol to fluticasone propionate versus increasing thedose of fluticasone propionate in patients with persistent asthma

Background: Current treatment guidelines define inhaled corticosteroids suc h as fluticasone propionate (FP) as the cornerstone of anti-inflammatory th erapy for asthma. Objective: The objective was to evaluate the efficacy and safety of adding salmeterol therapy to patients who remain symptomatic while receiving FP as compared with increasing the dose of FP. Methods: In a multicenter, double-blind study conducted over 24-weeks, 437 patients aged 12 years and older and receiving FP 88 mu g twice daily for 2 to 4 weeks were randomly assigned to receive either salmeterol (42 mu g tw ice daily) or FP 220 mu g twice daily. The primary efficacy endpoint was mo rning peak expiratory flow. Secondary measures included FEV1, symptom score s, nighttime awakenings, and supplemental albuterol use. Safety was assesse d by reported adverse events and asthma exacerbations. Results: The addition of salmeterol resulted in significantly greater impro vements in lung function and symptom control as compared with increasing th e dose of FP. Over weeks 1 to 24, morning peak expiratory flow was increase d by 47 L/min from baseline with salmeterol treatment as compared with 24 L /min with FP 220 mu g twice daily (P < .001) while the percent of symptom-f ree days increased from baseline by 26% of days as compared with 10% of day s (P < .001), The adverse event profiles were similar between groups and fe wer exacerbations were reported with salmeterol treatment. Conclusions: The addition of salmeterol therapy to patients who remain symp tomatic while using a low dose of FP was clinically and statistically super ior to increasing the dose of FP.