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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Korea, Republic of: Korea Food and Drug Administration
Study type Observational

Clinical Trial 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.


Description:

Study Design:


Recruitment information / eligibility

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).

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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