title: Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
abstract: BACKGROUND
  Combining maintenance medications with different mechanisms of action may improve outcomes in COPD. In this study we evaluated the efficacy and safety of fluticasone/salmeterol (FSC) (250/50 mcg twice daily) when added to tiotropium (18 mcg once daily) (TIO) in subjects with symptomatic moderate to severe COPD.
  
  
  METHODS
  This was a 24-week, randomized, double-blind, parallel group, multi-center study. Subjects 40 years or older with cigarette smoking history ≥10 pack-years and with the diagnosis of COPD and post-bronchodilator FEV(1) ≥40 to ≤ 80% of predicted normal and FEV(1)/FVC of ≤0.70 were enrolled. Following a 4-week treatment with open-label TIO 18 mcg once daily, subjects were randomized in a double-blind fashion to either the addition of FSC 250/50 DISKUS twice daily or matching placebo. The primary efficacy endpoint was AM pre-dose FEV(1) and secondary endpoints included other measures of lung function, rescue albuterol use, health status and exacerbations.
  
  
  RESULTS
  The addition of FSC to TIO significantly improved lung function indices including AM pre-dose FEV(1), 2 h post-dose FEV(1), AM pre-dose FVC, 2 h post-dose FVC and AM pre-dose IC compared with TIO alone. Furthermore, this combination was superior to TIO alone in reducing rescue albuterol use. However, there were no significant differences between the treatment groups in health status or COPD exacerbations. The incidence of adverse events was similar in both groups.
  
  
  CONCLUSIONS
  The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events. NCT00784550.
authors: Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.
authors: Nicola A
authors: NA
authors: Hanania
authors: Glenn D
authors: GD
authors: Crater
authors: Andrea N
authors: AN
authors: Morris
authors: Amanda H
authors: AH
authors: Emmett
authors: Dianne M
authors: DM
authors: O'Dell
authors: Dennis E
authors: DE
authors: Niewoehner
mesh_terms: D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000730:Androstadienes / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D012129:Respiratory Function Tests; D012602:Scopolamine Derivatives / Q000627:therapeutic use*; D000069447:Tiotropium Bromide; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D012602:Scopolamine Derivatives; D000420:Albuterol; D000069447:Tiotropium Bromide