This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent MDI in patients with chronic obstructive pulmonary disease (COPD).~Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent four times daily. Pulmonary function testing will be conducted just prior to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 120 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals at the end of therapy.~Study Hypothesis:~Null and alternative hypotheses The primary objective of this study was addressed by a two-sided test at the 0.05 level of significance of the null hypothesis that, in patients with chronic obstructive pulmonary disease (COPD), the bronchodilator efficacy after one month is no greater on tiotropium inhalation capsules (18mcg once daily) than on ATROVENT MDI (2 puffs of 20 mcg q.i.d.), against the alternative hypothesis that the bronchodilator efficacy is greater on tiotropium inhalation capsules (18 mcg once daily).~Comparison(s):~Trough FEV1 response will be analyzed. Peak FEV1, FVC trough and peak response, number of Rescue Medication and change from baseline in total score of Patient Evaluation Questionnaire will be analyzed. Change from baseline in each category score of Patient Evaluation Questionnaire will be also analyzed.
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)