Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239434
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2005-10-14
Brief Title:
A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler 2 Puffs of 20g 4 Times Daily in a Double-Blind Double-Dummy Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Comparison of 18 mg of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler 2 Puffs of 20 mg Four Times Daily in a Double-Blind Double-dummy Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2012-05
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 once daily dosing of tiotropium inhalation capsules 18 g and Atrovent MDI 2 puffs of ipratropium bromide 20 g four times daily in patients with chronic obstructive pulmonary disease
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 for 4 weeks Pulmonary function testing will be conducted just prior ie 5 minutes before to the start of therapy at Visit 2 ie randomization visit after completion of the 2-week run-in period and at 30 60 120 and 180 minutes post-dosing Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy visit 3 and at the end of therapy
Those patients taking theophylline will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements
Vital signs will be measured in conjunction with the pulmonary function tests Adverse events will be recorded throughout the entire run-in and treatment period
Study Hypothesis
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent
Comparisons
The primary pulmonary function variable will be FEV1 Forced Expiratory Volume in one second and trough FEV1 response at the end of the four week treatment period ie visit 4 will be the primary efficacy endpoint
Trough FEV1 is defined as FEV1 at the end of the dosing interval for tiotropium at approximately 24 hours post treatment administration On test days Visits 3 and 4 it is measured by the PFT just prior to dosing Trough FEV1 response is defined as change from baseline in trough FEV1 Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit Visit 2
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 for 4 weeks Pulmonary function testing will be conducted just prior ie 5 minutes before to the start of therapy at Visit 2 ie randomization visit after completion of the 2-week run-in period and at 30 60 120 and 180 minutes post-dosing Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy visit 3 and at the end of therapy
Those patients taking theophylline will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements
Vital signs will be measured in conjunction with the pulmonary function tests Adverse events will be recorded throughout the entire run-in and treatment period
Study Hypothesis
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent
Comparisons
The primary pulmonary function variable will be FEV1 Forced Expiratory Volume in one second and trough FEV1 response at the end of the four week treatment period ie visit 4 will be the primary efficacy endpoint
Trough FEV1 is defined as FEV1 at the end of the dosing interval for tiotropium at approximately 24 hours post treatment administration On test days Visits 3 and 4 it is measured by the PFT just prior to dosing Trough FEV1 response is defined as change from baseline in trough FEV1 Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit Visit 2
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