Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Comparison of 18 Mcg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 Mcg) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
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)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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