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 μg twice a day, is noninferior regarding symptom control compared with fluticasone propionate (FP), 200 μg 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 μg twice a day, during a 4-week runin 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 (FEV1, 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. Clinical trial registered with www.clinicaltrials.gov (NCT 00197106).

Additional Metadata
Keywords Asthma, Child, Inhaled corticosteroid, Long-acting β2-agonist
Persistent URL dx.doi.org/10.1164/rccm.201002-0193OC, hdl.handle.net/1765/21811
Citation
Vaessen-Verberne, A.A.P.H, van den Berg, N.J, Nierop, J.C, Brackel, H.J.L, Gerrit, G.P.J.M, Hop, W.C.J, & Duiverman, E.J. (2010). Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. American Journal of Respiratory and Critical Care Medicine, 182(10), 1221–1227. doi:10.1164/rccm.201002-0193OC