Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274053
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Effect of a 9-month Treatment of SPIRIVA on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease Validation of a New HRQoL Questionnaire Appropriate to Common Daily Practice TIPHON Study
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 purpose of this study is to investigate the effect of a 9-month treatment of tiotropium SPIRIVA 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease
Detailed Description:
This was a multicentre randomised double blind parallel group placebo-controlled 9 month study It was designed to determine the effect of inhaled tiotropium treatment on quality of life in patients with COPD
Following an initial 2-week screening period patients were randomized to either tiotropium or placebo at Visit 2 Patients returned to the clinic at month 3 Visit 3 6 Visit 4 and 9 Visit 5 for the conclusion of the trial The patients received treatment daily for 9 months
Quality of life was measured on each visit by using the Saint georges respiratory Questionnaire Additionally a short form questionnaire was developped for that study Visual Simplified Respiratory Questionnaire Lung function was also measured at each visit by spirometry
Study Hypothesis
The primary objective of this study is to compare the efficacy of Tiotropium and placebo on improving HRQoL evaluated by the percentage of SGRQ responders The null hypothesis is that there is no difference in the effect on HRQoL assessed by the percentage of SGRQ responders between the two treatment groups The alternative hypothesis is that there is a difference in effect on HRQoL assessed by the percentage of SGRQ responders between tiotropium and placebo The test will be performed at the alpha 005 level of significance
Comparisons
Tiotropium 18 mcg once daily vs Placebo
Following an initial 2-week screening period patients were randomized to either tiotropium or placebo at Visit 2 Patients returned to the clinic at month 3 Visit 3 6 Visit 4 and 9 Visit 5 for the conclusion of the trial The patients received treatment daily for 9 months
Quality of life was measured on each visit by using the Saint georges respiratory Questionnaire Additionally a short form questionnaire was developped for that study Visual Simplified Respiratory Questionnaire Lung function was also measured at each visit by spirometry
Study Hypothesis
The primary objective of this study is to compare the efficacy of Tiotropium and placebo on improving HRQoL evaluated by the percentage of SGRQ responders The null hypothesis is that there is no difference in the effect on HRQoL assessed by the percentage of SGRQ responders between the two treatment groups The alternative hypothesis is that there is a difference in effect on HRQoL assessed by the percentage of SGRQ responders between tiotropium and placebo The test will be performed at the alpha 005 level of significance
Comparisons
Tiotropium 18 mcg once daily vs 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