title: Comparison of the clinical efficacy and safety of salmeterol/fluticasone propionate versus current care in the management of persistent asthma in Korea.
abstract: OBJECTIVE
  In the Asia-Pacific region there is a general preference for prescribing oral over inhaled medications for the treatment of asthma. This study compared inhaled salmeterol/fluticasone propionate therapy (SFC) with physician-determined current care (CC) in the management of persistent asthma in Korea.
  
  
  METHODS
  Adult patients with a documented history of reversibility in FEV(1) (>or= 12%) or PEF (>or= 15%), were randomised in a 2:1 ratio to unblinded treatment with SFC (50/250 microg bd or 50/500 microg bd) via Diskus (N = 284) or CC (N = 140) for 52 weeks. Morning peak expiratory flow (PEF) (primary endpoint), exacerbations, asthma symptoms and patient-reported outcome measures were recorded.
  
  
  BACKGROUND
  GSK study number:100614.
  
  
  RESULTS
  At baseline, mean morning PEF in the SFC and CC group was 374 and 401 L/min respectively. The adjusted mean morning PEF at 52 weeks was 423 +/- 3 and 396 +/- 4 L/min for SFC and CC respectively (treatment difference of 27 +/- 5 in favour of SFC; 95% CI 17, 37; p < 0.0001). The mean rate of exacerbations over 52 weeks was significantly lower in the SFC group (SFC/CC odds ratio 0.57; 95% CI 0.44, 0.74; p < 0.0001). Treatment with SFC also resulted in a significantly greater improvement in asthma symptoms, in the number of patients assessed to have well controlled asthma (Asthma Control Test score >or= 20), and in a clinically significant improvement in overall Quality of Life. The incidence of adverse events was low and similar between the two groups and events were of the type expected in this population.
  
  
  CONCLUSIONS
  The results of this open-label, randomised study showed that SFC provided greater asthma control than CC in the management of persistent asthma.
authors.affiliation: Department of Internal Medicine, Hallym University, Anyang, Korea.
authors.forename: Ki-Suck
authors.initials: KS
authors.lastname: Jung
authors.forename: Soo-Taek
authors.initials: ST
authors.lastname: Uh
authors.forename: Yong-Chul
authors.initials: YC
authors.lastname: Lee
authors.forename: Jae-Jeong
authors.initials: JJ
authors.lastname: Shim
authors.forename: Soon-Kew
authors.initials: SK
authors.lastname: Park
authors.forename: Angela E
authors.initials: AE
authors.lastname: Williams
authors.forename: Robert
authors.initials: R
authors.lastname: Chan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007723:Korea; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol