Spiriva (Tiotropium Bromide) Assessment of FEV1 - (SAFE-Portugal).
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|ClinicalTrials.gov Identifier: NCT00239408|
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Device: Pulmonary function Testing Drug: tiotropium bromide||Phase 4|
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.
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.
Tiotropium bromide - 18 mcg capsule inhaled via the HandiHaler vs Placebo powder capsules for oral inhalation, via the HandiHaler.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||311 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||April 2004|
|Study Completion Date :||April 2004|
- Change in trough FEV1 after 12 weeks of treatment. [ Time Frame: week 12 ]
- Trough FEV1 at interim visit [ Time Frame: week 6 ]
- Change in FVC at weeks 6 and 12 [ Time Frame: week 6, week 12 ]
- Use of rescue medication (daytime and night-time) [ Time Frame: 12 weeks ]
- Assessment of COPD symptoms [ Time Frame: week 0, week 6, week 12 ]
- The Physician's Global Evaluation at Visits 2 and 4 [ Time Frame: week 0, week 12 ]
- Quality of life questionnaire (EQ-5D) at Visits 2 and 4 [ Time Frame: week 0, week 12 ]
- Pulse Rate [ Time Frame: 12 weeks ]
- Blood Pressure [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239408
|Study Chair:||Boehringer Ingelheim Study Coordinator||B.I. Portugal Lda|