Salmeterol/fluticasone propionate vs. double dose fluticasone propionate on lung function and asthma control in children

There is a large body of data to support the use of an inhaled corticosteroid (ICS) plus a long-acting beta(2)-agonist vs. increasing the dose of ICS in adults, but less data in children. This double-blind, parallel group, non-inferiority study compared lung function and asthma control, based on Global Initiative for Asthma guidelines, in children receiving either salmeterol/fluticasone propionate (SFC) 50/100 mu g bd (n = 160) or fluticasone propionate (FP) 200 mu g bd (n = 161) for 12 wks. Change from baseline in mean morning peak expiratory flow increased following both treatments, but was significantly greater in the SFC group compared with FP [Adjusted mean change (s.e.) (l/min): SFC: 26.9 (2.13), FP: 19.3 (2.12); treatment difference: 7.6 (3.01); 95% CI: 1.7, 13.5; p = 0.012)]. Asthma control improved over time in both groups. Mean pre-bronchodilator maximal-expiratory flow at 50% vital capacity and percentage rescue-free days showed significantly greater improvements in the SFC group compared with FP. All other efficacy indices showed comparable improvements in each group. Treatment with SFC 50/100 mu g bd compared with twice the steroid dose of FP (200 mu g bd), was at least as effective in improving individual clinical outcomes and overall asthma control, in asthmatic children previously uncontrolled on low doses of ICS.