https://scholars.lib.ntu.edu.tw/handle/123456789/523826
Title: | Double-blind randomized parallel group study comparing the efficacy and safety of tiotropium and ipratropium in the treatment of COPD patients in Taiwan | Authors: | Hsu J.-Y. Perng R.-P. Lu J.-Y. Wu C.-P. Huang M.-S. KWEN-TAY LUH PAN-CHYR YANG |
Issue Date: | 2006 | Publisher: | Scientific Communications International Ltd | Journal Volume: | 105 | Journal Issue: | 9 | Start page/Pages: | 708-714 | Source: | Journal of the Formosan Medical Association | Abstract: | Background/Purpose: To compare the efficacy and safety of tiotropium and ipratropium in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. Methods: This double-blind, randomized, placebo-controlled, parallel group study was conducted at six hospitals in Taiwan. COPD patients aged ? 40 years, with a forced expiratory volume in 1 second (FEV1) ? 65% of predicted and FEV1/forced vital capacity (FVC) ? 70% were enrolled. After a 2-week screening/baseline period, 132 patients were randomized to receive 4 weeks of treatment with either tiotropium 18 μg once daily from a dry powder inhaler (HandiHaler?) or two puffs of ipratropium. 20 μg four times daily from a metered dose inhaler. The primary outcome was the change in trough FEV1 from baseline to week 4. The secondary outcome measures were trough FVC response, FEV1 and FVC responses at 2 hours postinhalation. Results: After 4 weeks, trough FEV1 had increased by 61.7 ± 25.3 mL for tiotropium but decreased by 16.4 ± 27.9 mL for ipratropium. The difference between groups was significant (p < 0.05; 95% CI, 10-146.1). The trough FVC also increased by 137.2 ± 49.3 mL for tiotropium but was decreased by 84.5 ± 54.5 mL for ipratropium (p < 0.001; 95% CI, 89.0-354.3). No major drug-related adverse events associated with tiotropium and ipratropium were observed. Conclusion: Tiotropium 18 μg once daily using HandiHaler? was significantly more effective than ipratropium 40 μg four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable. ? 2006 Elsevier & Formosan Medical Association. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-33749345328&doi=10.1016%2fS0929-6646%2809%2960198-4&partnerID=40&md5=40059e64910cc37dcdd730f51a19ab68 https://scholars.lib.ntu.edu.tw/handle/123456789/523826 |
ISSN: | 0929-6646 | DOI: | 10.1016/S0929-6646(09)60198-4 | SDG/Keyword: | fenoterol; fenoterol plus ipratropium bromide; ipratropium bromide; ipratropium bromide plus salbutamol sulfate; placebo; tiotropium bromide; adult; aged; article; bronchodilating activity; chronic obstructive lung disease; clinical trial; comparative study; controlled clinical trial; controlled study; disease exacerbation; double blind procedure; drug efficacy; drug safety; forced expiratory volume; heart atrium fibrillation; human; lung disease; major clinical study; mass screening; metered dose inhaler; multicenter study; parallel design; powder inhaler; randomized controlled trial; side effect; statistical significance; Taiwan; treatment outcome; urinary frequency |
Appears in Collections: | 醫學系 |
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