A Comparison of Tiotropium 18㎍, Once Daily and Ipratropium 40㎍, 4 Times Daily in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease

Background : This study compared the bronchodilatorefficacy and safety of tiotropium inhalation capsules ( once daily) with a ipratropium metered dose inhaler(2 puffs of q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium once daily or ipratropiumfour times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second () and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted of 42 (12)% were analyzed. The trough response was significantly higher in the tiotropium group than in the ipratropiumgroup after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropiumgroup during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilatoreffect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.