Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274014
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Measure of the Long Term Influence of SPIRIVA in Acute Respiratory Disorders
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd Impact on Severity and Incidence of Exacerbations
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 objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease COPD
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations
Detailed Description:
This was a multicentre randomised double blind parallel group placebo-controlled one year study It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction PEFR incidence and severity of exacerbations in patients with COPD
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2 Patients returned to the clinic at weeks 6 Visit 3 12 Visit 4 24 Visit 5 36 Visit 6 48 Visit 7 and at Week 50 for the conclusion of the trial Visit 8 The patients received treatment daily for 48 weeks 336 days
PEFR as well as use of rescue medication and respiratory condition were self-assessed by patients and recorded every morning on a graphical diary card every morning The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet
Study Hypothesis
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease COPD
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations
Comparisons
Tiotropium 18 mcg once daily vs Placebo
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2 Patients returned to the clinic at weeks 6 Visit 3 12 Visit 4 24 Visit 5 36 Visit 6 48 Visit 7 and at Week 50 for the conclusion of the trial Visit 8 The patients received treatment daily for 48 weeks 336 days
PEFR as well as use of rescue medication and respiratory condition were self-assessed by patients and recorded every morning on a graphical diary card every morning The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet
Study Hypothesis
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease COPD
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations
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