title: Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  A total of 158 children, 6-16 years old, still symptomatic on FP, 100 μg 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.
authors.affiliation: Department of Pediatrics, Amphia Hospital, Breda, the Netherlands. avaessen-verberne@amphia.nl
authors.forename: Anna A P H
authors.initials: AA
authors.lastname: Vaessen-Verberne
authors.forename: Norbert J
authors.initials: NJ
authors.lastname: van den Berg
authors.forename: Jan C
authors.initials: JC
authors.lastname: van Nierop
authors.forename: Hein J L
authors.initials: HJ
authors.lastname: Brackel
authors.forename: Gerardus P J M
authors.initials: GP
authors.lastname: Gerrits
authors.forename: Wim C J
authors.initials: WC
authors.lastname: Hop
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Duiverman
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol