Salmeterol/fluticasone propionate vs. double dose fluticasone propionate on lung function and asthma control in children |
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Authors: | Jacques De Blic Ludmila Ogorodova Rabih Klink Irina Sidorenko Arunas Valiulis Jerzy Hofman Olav Bennedbaek Sally Anderton Valerie Attali Jean‐Luc Desfougeres Marc Poterre |
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Affiliation: | 1. Université Paris Descartes;2. Necker‐Enfant Malades Hospital, Paris, France;3. Department of Paediatrics, Siberian State Medical University, Russian Federation, Tomsk, Russia;4. General Hospital, Pulmonology Department, Laon, France;5. Moscow Medical Academy, City Clinic Hospital, Russian Federation, Moscow, Russia;6. Vilnius University Faculty of Medicine, Vilnius, Lithuania;7. Public Paediatric Teaching Hospital, Bialystok, Poland;8. Pediatric Clinic, Aalborg, Denmark;9. GlaxoSmithKline, Stockley Park, UK;10. GlaxoSmithKline, Marly le Roi, France |
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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. |
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Keywords: | salmeterol/fluticasone propionate fluticasone propionate half steroid dose asthma control children |
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