- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620516
Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients
November 18, 2013 updated by: Boehringer Ingelheim
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
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 Overview
Status
Completed
Conditions
Detailed Description
Study Design:
Study Type
Observational
Enrollment (Actual)
3008
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of
- Boehringer Ingelheim Investigational Site 1
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Busan, Korea, Republic of
- Boehringer Ingelheim Investigational Site 2
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Busan, Korea, Republic of
- Boehringer Ingelheim Investigational Site 3
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Busan, Korea, Republic of
- Boehringer Ingelheim Investigational Site 4
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Chugnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 5
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Chugnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 6
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Chugnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 7
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Chungbuk, Korea, Republic of
- Boehringer Ingelheim Investigational Site 69
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 10
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 11
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 12
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 13
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 8
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Daegu, Korea, Republic of
- Boehringer Ingelheim Investigational Site 9
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 14
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 15
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 16
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 17
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 18
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Daejeon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 19
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Gangwondo, Korea, Republic of
- Boehringer Ingelheim Investigational Site 20
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Gangwondo, Korea, Republic of
- Boehringer Ingelheim Investigational Site 21
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Gangwondo, Korea, Republic of
- Boehringer Ingelheim Investigational Site 22
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Gangwondo, Korea, Republic of
- Boehringer Ingelheim Investigational Site 23
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 24
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 25
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 26
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 27
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 28
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 29
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 30
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 31
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Gyeonggido, Korea, Republic of
- Boehringer Ingelheim Investigational Site 32
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Gyeongnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 70
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Gyeongnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 71
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Incheon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 33
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Incheon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 34
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Incheon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 35
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Incheon, Korea, Republic of
- Boehringer Ingelheim Investigational Site 36
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Jeonbuk, Korea, Republic of
- Boehringer Ingelheim Investigational Site 37
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Jeonbuk, Korea, Republic of
- Boehringer Ingelheim Investigational Site 38
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Jeonbuk, Korea, Republic of
- Boehringer Ingelheim Investigational Site 39
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 40
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 41
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 42
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 43
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 44
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 45
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Jeonnam, Korea, Republic of
- Boehringer Ingelheim Investigational Site 46
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 47
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 48
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 49
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 50
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 51
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 52
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 53
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 54
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 55
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 56
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 57
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 58
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 59
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 60
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 61
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 62
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 63
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 64
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 65
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 66
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Seoul, Korea, Republic of
- Boehringer Ingelheim Investigational Site 67
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Ulsan, Korea, Republic of
- Boehringer Ingelheim Investigational Site 68
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
3227
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: 30 days
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30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
February 4, 2008
First Submitted That Met QC Criteria
February 11, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205.337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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