Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239408
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-14
Brief Title:
Spiriva Tiotropium Bromide Assessment of FEV1 - SAFE-Portugal
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Spiriva Assessment of FEV1 - SAFE-Portugal The Effect of Inhaled Tiotropium Bromide 18 Mcg Once Daily on the Change in FEV1 During Treatment in Patients With COPD A Three-month Parallel Group Double-blind Randomised Placebo-controlled 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:
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced expiratory volume FEV1 compared to placebo in patients with chronic obstructive pulmonary disease COPD is affected by smoking status
Detailed Description:
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough FEV1 from baseline to week 12 compared to placebo in patients with COPD is affected by smoking status Secondary objectives include FEV1 at interim visit and FVC at on-treatment visits use of rescue medication COPD symptom scores Physicians Global Evaluation and EQ-5D scores
Study Hypothesis
The primary objective of the study is to show superiority of tiotropium against placebo with respect to trough FEV1 at 12 weeks Then the 5 two-sided hypotheses test is
H0 Mean trough FEV1 at 12 weeks in tiotropium Mean trough FEV1 at 12 weeks in placebo H1 Mean trough FEV1 at 12 weeks in tiotropium unequal Mean trough FEV1 at 12 weeks in placebo If the null hypothesis is rejected in favour of the alternative hypothesis H1 based on all patients the same hypotheses will be tested in both sub-populations of current and ex-smokers respectively
Comparisons
Tiotropium bromide - 18 mcg capsule inhaled via the HandiHaler vs Placebo powder capsules for oral inhalation via the HandiHaler
Study Hypothesis
The primary objective of the study is to show superiority of tiotropium against placebo with respect to trough FEV1 at 12 weeks Then the 5 two-sided hypotheses test is
H0 Mean trough FEV1 at 12 weeks in tiotropium Mean trough FEV1 at 12 weeks in placebo H1 Mean trough FEV1 at 12 weeks in tiotropium unequal Mean trough FEV1 at 12 weeks in placebo If the null hypothesis is rejected in favour of the alternative hypothesis H1 based on all patients the same hypotheses will be tested in both sub-populations of current and ex-smokers respectively
Comparisons
Tiotropium bromide - 18 mcg capsule inhaled via the HandiHaler vs Placebo powder capsules for oral inhalation via the HandiHaler
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