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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Design:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Korea, Republic of
      • Busan, 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
      • Chugnam, 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
      • Chungbuk, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 69
      • Daegu, 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
      • Daejeon, 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
      • Gangwondo, 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
      • Gyeonggido, 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
      • Gyeongnam, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 70
      • Gyeongnam, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 71
      • Incheon, 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
      • Jeonbuk, 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
      • Jeonnam, 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
      • Seoul, 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
      • Ulsan, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 68

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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