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 > or = 40 years, with a forced expiratory volume in 1 second (FEV1) < or = 65% of predicted and FEV1/forced vital capacity (FVC) < or = 70% were enrolled. After a 2-week screening/baseline period, 132 patients were randomized to receive 4 weeks of treatment with either tiotropium 18 microg once daily from a dry powder inhaler (HandiHaler) or two puffs of ipratropium 20 microg 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 microg once daily using HandiHaler was significantly more effective than ipratropium 40 microg four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable.