title: Predictive factors for evaluation of response to fluticasone propionate/salmeterol combination in severe COPD.
abstract: BACKGROUND
  The predictive factors for treatment response in patients with severe chronic obstructive pulmonary disease (COPD) are unknown. We investigated predictive factors for response to fluticasone propionate/salmeterol (FSC) in severe COPD patients.
  
  
  METHODS
  This prospective, open-label, non-comparative study included 921 adult patients with severe COPD (baseline forced expiratory volume in 1 s (FEV(1)) <50% of predicted), a history of repeated exacerbations, and symptoms despite bronchodilator treatment. FSC (500 μg/50 μg) was delivered via an inhaler, twice a day, for 12 weeks. The primary efficacy endpoint was the response rate for inspiratory capacity (IC), FEV(1), or quality of life (QoL), assessed with the Saint George's respiratory questionnaire, at week 6 and week 12.
  
  
  RESULTS
  The overall response rate to FSC at 6 and 12 weeks was 79%. The corresponding rates for FEV(1), IC, and QoL were 38%, 55%, and 62%, respectively. More than 40% of patients showed a response for IC and/or QoL without being responders for FEV(1.) Overall lung function and QoL were improved. FSC was well tolerated with a safety profile consistent with that observed previously.
  
  
  CONCLUSIONS
  Nearly 80% of patients responded to FSC treatment in this real-life study. Improvements in IC and QoL at 12 weeks revealed a clinically relevant response in patients with no improvement in FEV(1). IC reversibility to salbutamol before treatment might represent, better than FEV1, a prognostic factor of response to FSC in severe COPD. Moreover these tests are easy to perform routinely and in large numbers of patients.
authors.affiliation: Hôpital Albert Calmette, Boulevard du Pr Jules Leclercq, 59037 Lille Cedex, France. andretonnel@aol.com
authors.forename: Andre-Bernard
authors.initials: AB
authors.lastname: Tonnel
authors.forename: Isabelle
authors.initials: I
authors.lastname: Tillie-Leblond
authors.forename: Valerie
authors.initials: V
authors.lastname: Attali
authors.forename: Zola
authors.initials: Z
authors.lastname: Bavelele
authors.forename: Olivier
authors.initials: O
authors.lastname: Lagrange
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D005602:France; D006801:Humans; D008297:Male; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000420:Albuterol