| 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. CONCLUSION: Tiotropium significantly improved pulmonary function in African-American COPD patients. |
| Authors | Gerard J Criner, Amir Sharafkhaneh, Rick Player, Craig S Conoscenti, Philip Johnson, Mary Theresa Keyser, Cara Cassino
(Affiliation: Temple University School of Medicine, Temple University Hospital, Philadelphia, PA 19140, USA. Gerard.criner at tuhs.temple.edu)
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| Journal | COPD
(COPD)
Vol. 5
Issue 1
Pg. 35-41
(Feb 2008)
ISSN: 1541-2555 United States |
| PMID | 18259973
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
|
| Chemical References |
- Cholinergic Antagonists
- Powders
- Scopolamine Derivatives
- tiotropium
|
| Topics |
- Administration, Inhalation
- African Americans
- Cholinergic Antagonists
(administration & dosage)
- Double-Blind Method
- Female
- Follow-Up Studies
- Forced Expiratory Volume
(drug effects, physiology)
- Humans
- Male
- Middle Aged
- Powders
- Prospective Studies
- Pulmonary Disease, Chronic Obstructive
(drug therapy, ethnology, physiopathology)
- Questionnaires
- Scopolamine Derivatives
(administration & dosage)
- Treatment Outcome
- United States
(epidemiology)
|
