Efficacy of tiotropium inhalation powder in african-american patients with chronic obstructive pulmonary disease.
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.
Criner
Gerard J
GJ
Temple University School of Medicine, Temple University Hospital, Philadelphia, PA 19140, USA. Gerard.criner@tuhs.temple.edu
Sharafkhaneh
Amir
A
Player
Rick
R
Conoscenti
Craig S
CS
Johnson
Philip
P
Keyser
Mary Theresa
MT
Cassino
Cara
C
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
D018680:Cholinergic Antagonists; D011208:Powders; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide