title: Efficacy of tiotropium inhalation powder in african-american patients with chronic obstructive pulmonary disease.
abstract: BACKGROUND
  Responsiveness to pharmacologic agents may differ among subpopulations compared with the general population. In patients of African descent, possible differences have been observed for inhaled beta-agonists. However, pharmacologic responsiveness to a long-acting anticholinergic has not been prospectively evaluated.
  
  
  METHODS
  An 8-week, randomized, placebo-controlled clinical trial was conducted to assess the efficacy of the once-daily, inhaled anticholinergic tiotropium in COPD patients of African descent. African-American COPD patients > or =40 years, FEV(1) < or= 65% predicted, FEV(1)/FVC < or=70% were included. Spirometry (pre-study drug, and 0.5, 1, 2 and 3 hours post-dose) and the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) were performed at baseline and at 4 and 8 weeks. Data on use of rescue medication and on adverse events (including COPD exacerbations) were also collected.
  
  
  RESULTS
  Randomized patients (n = 166) were (mean +/- SD) 62.5 +/- 9.3 years; baseline mean FEV(1) 1.02 +/- 0.37 L (41 +/- 13% predicted); 67.5% were male. A total of 160 patients were eligible for efficacy evaluation. At 8 weeks, mean FEV(1) AUC(0 - 3) response was 180 mL greater with tiotropium (n = 78) than with placebo (n = 82), (p < 0.0001). Difference (tiotropium-placebo) for mean peak FEV(1) response was 182 mL (p < 0.0001) and 122 mL (p = 0.002) for mean trough FEV(1) response. There were no significant differences in SOBQ or use of rescue medication between the groups. No patients in the tiotropium group experienced a COPD exacerbation compared with 12 in patients receiving placebo.
  
  
  CONCLUSIONS
  Tiotropium significantly improved pulmonary function in African-American COPD patients.
authors.affiliation: Temple University School of Medicine, Temple University Hospital, Philadelphia, PA 19140, USA. Gerard.criner@tuhs.temple.edu
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Criner
authors.forename: Amir
authors.initials: A
authors.lastname: Sharafkhaneh
authors.forename: Rick
authors.initials: R
authors.lastname: Player
authors.forename: Craig S
authors.initials: CS
authors.lastname: Conoscenti
authors.forename: Philip
authors.initials: P
authors.lastname: Johnson
authors.forename: Mary Theresa
authors.initials: MT
authors.lastname: Keyser
authors.forename: Cara
authors.initials: C
authors.lastname: Cassino
mesh_terms: D000280:Administration, Inhalation; D001741:Black or African American; D018680:Cholinergic Antagonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011208:Powders; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D012602:Scopolamine Derivatives / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D000069447:Tiotropium Bromide; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D018680:Cholinergic Antagonists; D011208:Powders; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide