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 1
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
🇰🇷Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 3
🇰🇷Busan, 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 6
🇰🇷Chugnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 7
🇰🇷Chugnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 69
🇰🇷Chungbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
🇰🇷Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 11
🇰🇷Daegu, Korea, Republic of
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