Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144326
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-09-02
Brief Title:
A Randomised Double-blind Placebo-controlled 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules Spiriva on the Magnitude of Exercise Measured Using an Accelerometer in Patients With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules on the Magnitude of Exercise Measured Using an Accelerometer in Patients With Chronic Obstructive Pulmonary Disease COPD
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:
The objective of this study is to determine if tiotropium Spiriva Bromuro de Tiotropio 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity observed in COPD patients measured using an accelerometer
Detailed Description:
This is a 3 month multicentre randomised double-blind placebo controlled parallel group study to compare with placebo the long-term effect of tiotropium inhalation capsules on daily physical activity in patients with COPD
The drugs will be administered in the form of inhalation capsules of tiotropium or placebo taken once daily in the morning
The record of daily physical activity using the accelerometer will be carried out at all study visits other than Visit 1 The accelerometer will be used for the five day period from Thursday to Monday closest to the corresponding visit
The pulmonary function tests will be carried out at Visit 1 screening visit Visit 2 baseline visit and study visits Visits 3 to 5 with the restrictions detailed at the trial protocol
Study Hypothesis
The null hypothesis is that there is no difference between tiotropium Spiriva and placebo regarding the magnitude of exercise measured with an accelerometer The alternative hypothesis is that there is a difference between tiotropium Spiriva and placebo regarding the magnitude of exercise measured with an accelerometer
Comparisons
The difference in physical activity measured in vector magnitude units VMUs by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo
The drugs will be administered in the form of inhalation capsules of tiotropium or placebo taken once daily in the morning
The record of daily physical activity using the accelerometer will be carried out at all study visits other than Visit 1 The accelerometer will be used for the five day period from Thursday to Monday closest to the corresponding visit
The pulmonary function tests will be carried out at Visit 1 screening visit Visit 2 baseline visit and study visits Visits 3 to 5 with the restrictions detailed at the trial protocol
Study Hypothesis
The null hypothesis is that there is no difference between tiotropium Spiriva and placebo regarding the magnitude of exercise measured with an accelerometer The alternative hypothesis is that there is a difference between tiotropium Spiriva and placebo regarding the magnitude of exercise measured with an accelerometer
Comparisons
The difference in physical activity measured in vector magnitude units VMUs by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo
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