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Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients

NCT ID: NCT00620516

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Brief Summary

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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

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Study Design:

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 1

Busan, , South Korea

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Boehringer Ingelheim Investigational Site 2

Busan, , South Korea

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Boehringer Ingelheim Investigational Site 3

Busan, , South Korea

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Boehringer Ingelheim Investigational Site 4

Busan, , South Korea

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Boehringer Ingelheim Investigational Site 5

Chugnam, , South Korea

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Boehringer Ingelheim Investigational Site 6

Chugnam, , South Korea

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Boehringer Ingelheim Investigational Site 7

Chugnam, , South Korea

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Boehringer Ingelheim Investigational Site 10

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 11

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 12

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 13

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 8

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 9

Daegu, , South Korea

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Boehringer Ingelheim Investigational Site 14

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 15

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 16

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 17

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 18

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 19

Daejeon, , South Korea

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Boehringer Ingelheim Investigational Site 20

Gangwondo, , South Korea

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Boehringer Ingelheim Investigational Site 21

Gangwondo, , South Korea

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Boehringer Ingelheim Investigational Site 22

Gangwondo, , South Korea

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Boehringer Ingelheim Investigational Site 23

Gangwondo, , South Korea

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Boehringer Ingelheim Investigational Site 24

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 25

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 26

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 27

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 28

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 29

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 30

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 31

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 32

Gyeonggido, , South Korea

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Boehringer Ingelheim Investigational Site 70

Gyeongnam, , South Korea

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Boehringer Ingelheim Investigational Site 71

Gyeongnam, , South Korea

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Boehringer Ingelheim Investigational Site 33

Incheon, , South Korea

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Boehringer Ingelheim Investigational Site 34

Incheon, , South Korea

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Boehringer Ingelheim Investigational Site 35

Incheon, , South Korea

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Boehringer Ingelheim Investigational Site 36

Incheon, , South Korea

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Boehringer Ingelheim Investigational Site 37

Jeonbuk, , South Korea

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Boehringer Ingelheim Investigational Site 38

Jeonbuk, , South Korea

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Boehringer Ingelheim Investigational Site 39

Jeonbuk, , South Korea

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Boehringer Ingelheim Investigational Site 40

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 41

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 42

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 43

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 44

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 45

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 46

Jeonnam, , South Korea

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Boehringer Ingelheim Investigational Site 69

Jungbuk, , South Korea

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Boehringer Ingelheim Investigational Site 47

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 48

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 49

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 50

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 51

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 52

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 53

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 54

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 55

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 56

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 57

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 58

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 59

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 60

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 61

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 62

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 63

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 64

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 65

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 66

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 67

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site 68

Ulsan, , South Korea

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Countries

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South Korea

Other Identifiers

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205.337

Identifier Type: -

Identifier Source: org_study_id