title: Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.
abstract: BACKGROUND
  Little is known about factors that determine health status decline in clinical trials of COPD.
  
  
  OBJECTIVE
  To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.
  
  
  METHODS
  St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.
  
  
  RESULTS
  Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.
  
  
  CONCLUSIONS
  In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00268216.
authors.affiliation: Department of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK. pjones@sgul.ac.uk
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
authors.forename: Julie A
authors.initials: JA
authors.lastname: Anderson
authors.forename: Peter Ma
authors.initials: PM
authors.lastname: Calverley
authors.forename: Bartolome R
authors.initials: BR
authors.lastname: Celli
authors.forename: Gary T
authors.initials: GT
authors.lastname: Ferguson
authors.forename: Christine
authors.initials: C
authors.lastname: Jenkins
authors.forename: Julie C
authors.initials: JC
authors.lastname: Yates
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
authors.forename: Michael D
authors.initials: MD
authors.lastname: Spencer
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001208:Asia; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D004338:Drug Combinations; D005060:Europe; D005260:Female; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000627:therapeutic use*; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D008168:Lung / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D000068299:Salmeterol Xinafoate; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol