The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. The secondary objective of the study includes assessments of the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The third objective of the study is to investigate the correlation between the results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Change from baseline in 6 Minute Walking Distance (6MWD)
Time frame: Baseline, day 51
Dyspnoea at the end of the 6MWT determined by the Modified Borg Scale (Dyspnoea Borg 6MWT),
Time frame: Up to day 51
Endurance time during a constant work rate exercise test (CWR)
Time frame: Up to day 51
Forced expiratory volume in one second (FEV1)
Time frame: Up to day 51
Forced vital capacity (FVC)
Time frame: Up to day 51
Slow vital capacity (SVC)
Time frame: Up to day 51
Total lung capacity (TLC)
Time frame: Up to day 51
COPD symptom scores (wheezing, shortness of breath, coughing, and tightness of chest)
Time frame: Up to day 51
Transition Dyspnoea Indices (TDI)
Time frame: Up to day 51
Change from baseline in Chronic Respiratory Questionnaire (CRQ),
Time frame: Baseline, up to day 51
Change from baseline in patient's global evaluation on an 8-point-scale
Time frame: Baseline, up to day 51
Amount of rescue medication used
Time frame: Up to day 51
Daily physical activity, measured by a pedometer as number of registered activity impulses per day
Time frame: Up to day 51
Total duration of endurance training on cycle ergometer during rehabilitation period
Time frame: Up to day 51
Occurrence of adverse events
Time frame: Up to day 51
Static Inspiratory capacity (IC)
Time frame: Up to day 51
Residual volume (RV)
Time frame: Up to day 51
Thoracic gas volume (TGV)
Time frame: Up to day 51
Airways resistance (Raw)
Time frame: Up to day 51
Change from baseline in blood pressure
Time frame: Baseline, day 51
Change from baseline in pulse rate
Time frame: Baseline, day 51
Change from baseline in laboratory tests
Time frame: Baseline, day 51
Change from baseline in electrocardiogram (ECG)
Time frame: Baseline, day 51
Change from baseline in physician's global evaluation on an 8-point-scale
Time frame: Baseline, up to day 51
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