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

Abstract

There is a large body of data to support the use of an inhaled corticosteroid (ICS) plus a long‐acting β2‐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 μg bd (n = 160) or fluticasone propionate (FP) 200 μg 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 μg bd compared with twice the steroid dose of FP (200 μg 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.

A Systematic Review of Long-Acting β2-Agonists Versus Higher Doses of Inhaled Corticosteroids in Asthma

“…Nine RCTs, [14][15][16][17][18][19][20][21][22] involving a total of 1641 children and adolescents, fulfilled the inclusion criteria (Fig 1). One trial was unpublished.…”

“…21 Intervention groups received BDP equivalent doses of 400 mg/d in 7 studies 14,[16][17][18][19][20]22 and 200 mg/d in 2 studies. 15,21 The dose of ICS that the control group received was twice, [14][15][16][17][18][19][20] or more than twice, the amount received by the LABA/ICS group. 21,22 Rescue medications, such as inhaled short-acting b2-agonists and systemic steroids, were permitted in all the trials.…”

“…21,22 Rescue medications, such as inhaled short-acting b2-agonists and systemic steroids, were permitted in all the trials. Most of the studies 14,[16][17][18][19][20][21] were funded by the pharmaceutical industry. Six studies [16][17][18][20][21][22] were judged to have a low risk of bias (successfully complied with at least 5 of the 6 domains of bias assessment) ( Table 2).…”

“…The mean age of participants was 9 years (range 4-17), with 59% being male. Eight trials 14,[16][17][18][19][20][21][22] included subjects with inadequately controlled asthma, low doses of ICS (200-500 µg/ d beclomethasone dipropionate [BDP] or equivalent). The remaining study recruited children with mild asthma.…”

Assessment of Controversial Pediatric Asthma Management Options Using GRADE

“…[43][44][45] Four RCTs (2 from Cochrane review and 2 more recently published trials) were included. 40,42,46,47 Children with ongoing symptoms during ICS use were randomized to either a double dose of ICS or adding an LABA. Only 1 study included a third arm: adding an LTRA to ICS.…”