Double-blind Randomized Parallel Group Study Comparing the Efficacy and Safety of Tiotropium and Ipratropium in the Treatment of COPD Patients in Taiwan

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 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.