Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium | Experimental |
| |
| Oxitropium bromide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium powder inhalation capsules | Drug | Powder inhalation via the HandiHaler® once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events | up to 52 weeks | |
| Changes from baseline in Blood Pressure / Heart Rate | up to 52 weeks | |
| Changes from baseline in ECG | up to 52 weeks | |
| Changes from baseline in laboratory tests | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response | week 24 and 52 | |
| Changes from baseline in FEV1.0 at 1 hr post-dosing | week 24 and 52 | |
Not provided
Inclusion Criteria:
The patients with COPD (chronic bronchitis, emphysema) whose symptoms are stable and who satisfy the following criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tersigan® |
| Drug |
2 puffs of oxitropium three times daily via MDI |
|
| Changes from baseline in Trough Forced vital capacity (FVC) response |
| week 24 and 52 |
| Changes from baseline in FVC at 1 hr post-dosing | week 24 and 52 |
| Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep) | up to 52 weeks |
| Frequency of rescue use of β2 stimulants | up to 2 weeks |
| Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible) | week 24 and 52 |
| Patient's impression | week 24 and 52 |
| Physician's global evaluation | week 24 and 52 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided