Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study
NCT number | NCT00620516 |
Other study ID # | 205.337 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | February 4, 2008 |
Last updated | November 18, 2013 |
Start date | March 2004 |
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.
Status | Completed |
Enrollment | 3008 |
Est. completion date | |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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). |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | 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 | Boehringer Ingelheim Investigational Site 12 | Daegu | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 13 | Daegu | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 8 | Daegu | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 9 | 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 17 | Daejeon | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 18 | Daejeon | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 19 | Daejeon | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 20 | Gangwondo | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 21 | Gangwondo | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 22 | Gangwondo | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 23 | Gangwondo | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 24 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 25 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 26 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 27 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 28 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 29 | Gyeonggido | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 30 | 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 70 | Gyeongnam | |
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 37 | Jeonbuk | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 38 | Jeonbuk | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 39 | Jeonbuk | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 40 | Jeonnam | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 41 | Jeonnam | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 42 | 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 45 | Jeonnam | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 46 | Jeonnam | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 47 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 48 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 49 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 50 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 51 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 52 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 53 | 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 59 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 60 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 61 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 62 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 63 | 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 66 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 67 | Seoul | |
Korea, Republic of | Boehringer Ingelheim Investigational Site 68 | Ulsan |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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