Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257452
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-11-21
Brief Title:
A Double-blind Randomised Study to Assess the Influence of Tiotropium Spiriva
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Double-blind Randomised Placebo Controlled Three-way Cross-over Study With an Open Label Positive Control Moxifloxacin to Assess the Influence of Inhaled Tiotropium Once Daily Over Twelve Days on the QTC Interval of the ECG in Healthy Male and Female Volunteers
Status:
COMPLETED
Status Verified Date:
2013-10
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:
To demonstrate that tiotropium Spiriva does not prolong the QT interval of the ECG more than placebo
Detailed Description:
The objective of this study is to demonstrate that tiotropium does not prolong the QT interval more than placebo This will be achieved by testing non-inferiority hypothesis
Study Hypothesis
There is one primary variable to be tested for non-inferiority tiotropium high dose compared to placebo
H0 µTIO12 - µPBO12 10 ms vs H1 µTIO12 - µPBO12 10 ms where µTIO12 µPBO12 represent the mean change from baseline QTcF between 5 minutes and 2 hours after 12 days of treatment taking the mean of the time-matched differences between baseline and post-baseline values in each treatment period with tiotropium 54 µg or placebo respectively
If the data suggest that the Fridericia correction is poor for the study population an alternative correction will be explored QTcN The other correction formula would be used as a replacement for the Fridericia correction and would be defined before unblinding of the data
Comparisons
Placebo moxifloxacin as active control
Study Hypothesis
There is one primary variable to be tested for non-inferiority tiotropium high dose compared to placebo
H0 µTIO12 - µPBO12 10 ms vs H1 µTIO12 - µPBO12 10 ms where µTIO12 µPBO12 represent the mean change from baseline QTcF between 5 minutes and 2 hours after 12 days of treatment taking the mean of the time-matched differences between baseline and post-baseline values in each treatment period with tiotropium 54 µg or placebo respectively
If the data suggest that the Fridericia correction is poor for the study population an alternative correction will be explored QTcN The other correction formula would be used as a replacement for the Fridericia correction and would be defined before unblinding of the data
Comparisons
Placebo moxifloxacin as active control
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