ABSTRACT
BACKGROUND: The role of combination ICS/LABA as initial controller therapy in mild, persistent asthma is uncertain. Therefore, the objective of this study was to compare the efficacy of initial controller therapy with fluticasone propionate (FP) 100 microg twice daily to the efficacy of fluticasone propionate/salmeterol xinafoate (FSC) 100/50 microg twice daily in patients with persistent asthma symptoms while using as-needed SABA alone. METHODS: This randomized, double-blind, parallel-group study was conducted at 45 general practice and 15 specialist centers. A total of 526 adult patients were randomized to receive FP or FSC for 24 weeks. The primary efficacy endpoint was change in morning peak expiratory flow (PEF) from baseline. Secondary efficacy endpoints included symptom- and rescue-free days; asthma exacerbation rate; asthma-related health-care utilization; and the onset of effect. Safety was assessed by monitoring adverse events. RESULTS: Mean morning PEF was significantly greater in the FSC versus the FP group (P<0.001); this greater effect was evident as early as the first week of treatment (P<0.001). The percentages of symptom-free days and rescue-free days in the FSC group were 7.7% (P=0.009) and 8.4% (P=0.001) higher than the FP group, respectively. Trends toward lower exacerbation-related health care-utilization for FSC versus FP were not statistically significant and exacerbation rates were not significantly different. The incidence of adverse events was low with both treatments. CONCLUSIONS: :Treatment with FSC was a more effective initial controller therapy than FP monotherapy in ICS-naïve patients who had uncontrolled asthma while using as-needed SABA alone.
