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This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.
Study Design:
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva® 18 mcg inhalation capsule | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints include change in post bronchodilator FEV1 and assessment of any change in overall severity of the disease from baseline to the end of 30 day treatment. | 30 days |
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Inclusion Criteria:
Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label
Exclusion Criteria:
patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
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3227
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Busan | South Korea | ||||
| Boehringer Ingelheim Investigational Site 2 |
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| Busan |
| South Korea |
| Boehringer Ingelheim Investigational Site 3 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Chugnam | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Chugnam | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Chugnam | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 70 | Gyeongnam | South Korea |
| Boehringer Ingelheim Investigational Site 71 | Gyeongnam | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 37 | Jeonbuk | South Korea |
| Boehringer Ingelheim Investigational Site 38 | Jeonbuk | South Korea |
| Boehringer Ingelheim Investigational Site 39 | Jeonbuk | South Korea |
| Boehringer Ingelheim Investigational Site 40 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 41 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 42 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 43 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 44 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 45 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 46 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 47 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 48 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 49 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 50 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 51 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 52 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 53 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 54 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 55 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 56 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 57 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 58 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 59 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 60 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 61 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 62 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 63 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 64 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 65 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 66 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 67 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 69 | Taebuk | South Korea |
| Boehringer Ingelheim Investigational Site 68 | Ulsan | South Korea |
| 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 |
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