title: The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD.
abstract: BACKGROUND
  Few studies of the efficacy and safety of therapy with combinations of salmeterol/fluticasone propionate (SFCs) have been conducted in Chinese patients with COPD, and the benefits of combination therapy in nonsmoking patients with COPD are, to our knowledge, not known.
  
  
  OBJECTIVE
  The aims were to establish the efficacy and tolerability of the therapy with SFC (salmeterol, 50 microg/fluticasone, 500 microg, twice daily) in the management of Chinese COPD patients and to investigate the effectiveness of SFC in nonsmokers with COPD.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Changes in prebronchodilator and postbronchodilator FEV(1), quality of life determined by the St. George Respiratory Questionnaire (SGRQ) scores, relief bronchodilator use, nighttime awakenings, and frequency of exacerbations of COPD were measured in patients randomized to receive SFC (n = 297) or placebo (n = 148). Never-smokers, former smokers, and current smokers accounted for 11.7%, 66.7%, and 21.6%, respectively, of the study population.
  
  
  RESULTS
  After 24 weeks, the mean changes in prebronchodilator and postbronchodilator FEV(1) were 180 mL (95% confidence interval [CI], approximately 91 to 268; p < 0.001) and 65 mL (95% CI, approximately 14 to 115; p = 0.012), respectively, greater for the SFC group than that for the placebo group. The differences in response to treatment were significant (all p < 0.0001) in former or current smokers but not in never-smokers (p > 0.05). The mean improvement in the total SGRQ score for the SFC group was 5.74 (p < 0.01) greater than that for the placebo group. SFC significantly reduced the frequency of nighttime awakenings and the use of relief bronchodilator. The adjusted ratio of exacerbations of COPD for the SFC group relative to the placebo group was 0.61 (95% CI, approximately 0.45 to 0.84; p < 0.01). There were no significant differences between the SFC and placebo groups in safety measures.
  
  
  CONCLUSIONS
  SFC therapy achieved sustained improvement in lung function, quality of life, and control of symptoms, and was well tolerated in Chinese patients. Greater improvements in lung function were found only for COPD patients with a history of smoking.
  
  
  BACKGROUND
  http://ctr.gsk.co.uk/Summary/fluticasone_salmeterol/studylist.asp Identifier: No. SCO100540.
authors.affiliation: Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College, Guangzhou 510120, People's Republic of China.
authors.forename: Jin-Ping
authors.initials: JP
authors.lastname: Zheng
authors.forename: Lan
authors.initials: L
authors.lastname: Yang
authors.forename: Ya Mei
authors.initials: YM
authors.lastname: Wu
authors.forename: Ping
authors.initials: P
authors.lastname: Chen
authors.forename: Zhong Guang
authors.initials: ZG
authors.lastname: Wen
authors.forename: Wen-Jie
authors.initials: WJ
authors.lastname: Huang
authors.forename: Yi
authors.initials: Y
authors.lastname: Shi
authors.forename: Chang-Zheng
authors.initials: CZ
authors.lastname: Wang
authors.forename: Shao-Guang
authors.initials: SG
authors.lastname: Huang
authors.forename: Tie-ying
authors.initials: TY
authors.lastname: Sun
authors.forename: Guang-Fa
authors.initials: GF
authors.lastname: Wang
authors.forename: Sheng-Dao
authors.initials: SD
authors.lastname: Xiong
authors.forename: Nan-Shan
authors.initials: NS
authors.lastname: Zhong
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010919:Placebos; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology / Q000208:ethnology; D011788:Quality of Life; D000068299:Salmeterol Xinafoate; D012907:Smoking / Q000009:adverse effects / Q000453:epidemiology; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D010919:Placebos; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol