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.
RCT Entities:
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 COPDpatients of African descent. African-American COPDpatients > 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 COPDpatients.
Authors: MeiLan K Han; Douglas Curran-Everett; Mark T Dransfield; Gerard J Criner; Lening Zhang; James R Murphy; Nadia N Hansel; Dawn L DeMeo; Nicola A Hanania; Elizabeth A Regan; Barry J Make; Fernando J Martinez; Gloria E Westney; Marilyn G Foreman Journal: Chest Date: 2011-06-02 Impact factor: 9.410
Authors: Marc Miravitlles; David Price; Klaus F Rabe; Hendrik Schmidt; Norbert Metzdorf; Bartolome Celli Journal: Int J Chron Obstruct Pulmon Dis Date: 2015-03-16
Authors: Shannon Cope; James F Donohue; Jeroen P Jansen; Matthias Kraemer; Gorana Capkun-Niggli; Michael Baldwin; Felicity Buckley; Alexandra Ellis; Paul Jones Journal: Respir Res Date: 2013-10-07