Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157235
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-07
Brief Title:
Effect of Tiotropium Inhalation Capsules Spiriva on Exercise Tolerance in COPD Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
Status:
COMPLETED
Status Verified Date:
2017-12
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 trial is to determine whether tiotropium inhalation capsules Spiriva Bromuro de Tiotropio compared to placebo enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease COPD who participate in pulmonary rehabilitation
Detailed Description:
This is an 25-week multicenter single country randomised double-blind placebo-controlled parallel group study to compare the efficacy of tiotropium inhalation capsules Spiriva Bromuro de Tiotropio in patients with COPD participating in a pulmonary rehabilitation program
Following an initial screening patients will perform a six minute walk test Visit 1 and enter a 4-week run-in period Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks After successfully completing 4 weeks of study drug self-administration patients will enter a period of pulmonary rehabilitation
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks After the last pulmonary rehabilitation session patients will continue on study medication for a 12 week follow-up period
Six minute walk tests will be repeated during the run-in period at Week 0 Visit 2 and Week 4 Visit 3 at the conclusion of the 8 weeks of pulmonary rehabilitation Visit 6 and the 12 weeks of follow-up Visit 9
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 week 0 3 week 4 6 week 13 and 9 week 25
Study Hypothesis
The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation However the two-sided test of hypothesis will be performed at 005 level of significance
Comparisons
The primary endpoint is the six minute walk distance at visit 6 This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment center and baseline six-minute walk distance measured at visit 2 prior to dosing as a covariate Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium Spiriva Bromuro de Tiotropio and placebo at 5 level of significance with at least 80 power using a two-tailed t-test
Following an initial screening patients will perform a six minute walk test Visit 1 and enter a 4-week run-in period Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks After successfully completing 4 weeks of study drug self-administration patients will enter a period of pulmonary rehabilitation
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks After the last pulmonary rehabilitation session patients will continue on study medication for a 12 week follow-up period
Six minute walk tests will be repeated during the run-in period at Week 0 Visit 2 and Week 4 Visit 3 at the conclusion of the 8 weeks of pulmonary rehabilitation Visit 6 and the 12 weeks of follow-up Visit 9
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 week 0 3 week 4 6 week 13 and 9 week 25
Study Hypothesis
The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation However the two-sided test of hypothesis will be performed at 005 level of significance
Comparisons
The primary endpoint is the six minute walk distance at visit 6 This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment center and baseline six-minute walk distance measured at visit 2 prior to dosing as a covariate Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium Spiriva Bromuro de Tiotropio and placebo at 5 level of significance with at least 80 power using a two-tailed t-test
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