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Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma.

Author(s): Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ

Affiliation(s): Department of Pediatrics, Amphia Hospital, Breda, the Netherlands. avaessen-verberne@amphia.nl

Publication date & source: 2010-11-15, Am J Respir Crit Care Med., 182(10):1221-7. Epub 2010 Jul 9.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

RATIONALE: For children with symptomatic asthma despite low to moderate doses of inhaled corticosteroids, evidence is still lacking whether to add a long-acting bronchodilator or to increase the dose of inhaled corticosteroids. OBJECTIVE: To evaluate whether salmeterol/fluticasone propionate (SFP), 50/100 mug twice a day, is noninferior regarding symptom control compared with fluticasone propionate (FP), 200 mug twice a day Diskus in children with symptomatic asthma. METHODS: A multicenter, randomized, parallel-group, double-blind study was performed comparing SFP and FP treatment during 26 weeks on asthma control and lung function. MEASUREMENTS AND MAIN RESULTS: A total of 158 children, 6-16 years old, still symptomatic on FP, 100 mug twice a day, during a 4-week run-in period, were included. Percentage of symptom-free days during the last 10 weeks of the treatment period did not differ between treatment groups (per protocol analysis: adjusted mean difference [FP minus SFP] 2.6%; 95% confidence interval, -8.1 to 13.4). Both groups showed substantial improvements of about 25 percent points in symptom-free days (both P < 0.001 from baseline). Lung function measurements (FEV(1), FVC, PEF rate, and maximal expiratory flow) did not differ between groups except for a slight advantage in maximal expiratory flow in the SFP group at 1 week. No differences were found between FP and SFP regarding exacerbation rates, adverse events, or growth. CONCLUSIONS: In our study the efficacy on symptom control and lung function of the combination of a long-acting bronchodilator with inhaled corticosteroid is equal to doubling the dose of the inhaled corticosteroid in children still symptomatic on a moderate dose of inhaled corticosteroid.

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