Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00620516
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Study Design:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3008
Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label
patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (71)
Boehringer Ingelheim Investigational Site 70
🇰🇷Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 45
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 69
🇰🇷Chungbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 13
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 30
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 7
🇰🇷Chugnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 4
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
🇰🇷Chugnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 1
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 3
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 11
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 68
🇰🇷Ulsan, Korea, Republic of
Boehringer Ingelheim Investigational Site 63
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 6
🇰🇷Chugnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 8
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 19
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 23
🇰🇷Gangwondo, Korea, Republic of
Boehringer Ingelheim Investigational Site 12
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 14
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 15
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 16
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 9
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 17
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 24
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
🇰🇷Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 21
🇰🇷Gangwondo, Korea, Republic of
Boehringer Ingelheim Investigational Site 25
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 20
🇰🇷Gangwondo, Korea, Republic of
Boehringer Ingelheim Investigational Site 22
🇰🇷Gangwondo, Korea, Republic of
Boehringer Ingelheim Investigational Site 27
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 29
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 26
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 28
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 31
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 32
🇰🇷Gyeonggido, Korea, Republic of
Boehringer Ingelheim Investigational Site 71
🇰🇷Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 33
🇰🇷Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 34
🇰🇷Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 35
🇰🇷Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 36
🇰🇷Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 38
🇰🇷Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 37
🇰🇷Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 40
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 39
🇰🇷Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 42
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 41
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 43
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 44
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 46
🇰🇷Jeonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 48
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 47
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 49
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 51
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 53
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 52
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 54
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 55
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 56
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 57
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 58
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 61
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 60
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 62
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 64
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 65
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 67
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 59
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 50
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 66
🇰🇷Seoul, Korea, Republic of