Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274092
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2006-01-09
Brief Title:
Efficacy and Safety of Tiotropium Inhalation Capsules and Atrovent MDI in Patients With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 qid in patients with chronic obstructive pulmonary disease COPD
Detailed Description:
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 ie 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 005 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 qid against the alternative hypothesis that the bronchodilator efficacy is greater on tiotropium inhalation capsules 18 mcg once daily
Comparisons
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
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 ie 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 005 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 qid against the alternative hypothesis that the bronchodilator efficacy is greater on tiotropium inhalation capsules 18 mcg once daily
Comparisons
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None