title: 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 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 microg bd (n = 160) or fluticasone propionate (FP) 200 microg 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 microg bd compared with twice the steroid dose of FP (200 microg 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.
authors.affiliation: Université Paris Descartes; Necker-Enfant Malades Hospital, 75015 Paris, France. j.deblic@nck.aphp.fr
authors.forename: Jacques
authors.initials: J
authors.lastname: de Blic
authors.forename: Ludmila
authors.initials: L
authors.lastname: Ogorodova
authors.forename: Rabih
authors.initials: R
authors.lastname: Klink
authors.forename: Irina
authors.initials: I
authors.lastname: Sidorenko
authors.forename: Arunas
authors.initials: A
authors.lastname: Valiulis
authors.forename: Jerzy
authors.initials: J
authors.lastname: Hofman
authors.forename: Olav
authors.initials: O
authors.lastname: Bennedbaek
authors.forename: Sally
authors.initials: S
authors.lastname: Anderton
authors.forename: Valerie
authors.initials: V
authors.lastname: Attali
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Desfougeres
authors.forename: Marc
authors.initials: M
authors.lastname: Poterre
mesh_terms: D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol