Double-Blind Randomized Parallel Group Study Comparing the Efficacy and Safety of Tiotropium and Ipratropium in the Treatment of Copd Patients in Taiwan
Resource
JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION v.105 n.9 pp.708-714
Journal
JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION
Journal Volume
v.105
Journal Issue
n.9
Pages
708-714
Date Issued
2006
Date
2006
Author(s)
HSU, JENG-YUAN
PENG, JUI-PENG
LU, JAU- YEONG
WU, CHIN-PYNG
HUANG, MING-SHYAN
LUH, KWEN-TAY
YANG, PAN-CHYR
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 (FEV 1) <= 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 mu g once daily from a dry powder inhaler (HandiHaler (R)) or two puffs of ipratropium 20 mu g 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% Cl, 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% Cl, 89.0-354.3). No major drug- related adverse events associated with tiotropium and ipratropium were observed. Conclusion: Tiotropium 18 mu g once daily using HandiHater (R) was significantly more effective than ipratropium 40 mu g four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable.
Subjects
chronic obstructive
pulmonary disease HandiHaler
ipratropium
metered dose inhaler
tiotropium