The primary objective of this study is to investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. \<35% of predicted FEV1, moderate COPD, i.e. 35% - \<50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society \[ATS\] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,639
Boehringer Ingelheim Investigational Site
Aachen, Germany
Boehringer Ingelheim Investigational Site
Ahrensburg, Germany
Boehringer Ingelheim Investigational Site
Altenburg, Germany
Boehringer Ingelheim Investigational Site
Amberg, Germany
Boehringer Ingelheim Investigational Site
Aschaffenburg, Germany
Change from baseline in trough FEV1 (Forced expiratory volume in one second)
Time frame: after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
Time frame: after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
Time frame: Day 1
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Time frame: Day 1 and 85
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Time frame: Day 1 and 85
Number of patients having a COPD exacerbation
Time frame: 12 weeks
Number of patients being hospitalised due to a COPD exacerbation
Time frame: 12 weeks
Number of COPD exacerbations per patient
Time frame: 12 weeks
Number hospitalisations due to COPD exacerbations per patient
Time frame: 12 weeks
Duration of COPD exacerbations per patient
Time frame: 12 weeks
Duration of hospitalisations due to a COPD exacerbation
Time frame: 12 weeks
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Boehringer Ingelheim Investigational Site
Aue, Germany
Boehringer Ingelheim Investigational Site
Auerbach, Germany
Boehringer Ingelheim Investigational Site
Augsburg, Germany
Boehringer Ingelheim Investigational Site
Backnang, Germany
Boehringer Ingelheim Investigational Site
Bad Kissingen, Germany
...and 167 more locations