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CompletedNCT00620516Updated Nov 19, 2013

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

An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 71 sites in Korea, Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
3,008
Ages
40 Years and older
Sex
All
01

Study 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.

Read the detailed description

Study Design:

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 3,008 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

3227

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

Exclusion Criteria:

patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).

05

Study design

Time perspective
Prospective
Enrollment
3,008 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

71 sites
  • 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, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00620516
Lead sponsor
Boehringer Ingelheim
First posted
Feb 21, 2008
Start date
Mar 2004
Primary completion
Dec 2007
Last update
Nov 19, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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