Pulmonary Disease, Chronic ObstructiveNCT00620516

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 71 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 3,008 participants
Where: 71 sitesSouth Korea
Study dates: Mar 2004to Dec 2007
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 3227

Who may be able to join

Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label

Who cannot join

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

Trial locations and contacts

71 sites in 1 country.

City, postcode or hospital

71 sites in 1 country

South Korea71 sites

Boehringer Ingelheim Investigational Site 1
Busan
Boehringer Ingelheim Investigational Site 2
Busan
Boehringer Ingelheim Investigational Site 3
Busan
Boehringer Ingelheim Investigational Site 4
Busan
Boehringer Ingelheim Investigational Site 5
Chugnam
Boehringer Ingelheim Investigational Site 6
Chugnam
Boehringer Ingelheim Investigational Site 7
Chugnam
Boehringer Ingelheim Investigational Site 10
Daegu
Boehringer Ingelheim Investigational Site 11
Daegu
Boehringer Ingelheim Investigational Site 12
Daegu
Boehringer Ingelheim Investigational Site 13
Daegu
Boehringer Ingelheim Investigational Site 8
Daegu
Boehringer Ingelheim Investigational Site 9
Daegu
Boehringer Ingelheim Investigational Site 14
Daejeon
Boehringer Ingelheim Investigational Site 15
Daejeon
Boehringer Ingelheim Investigational Site 16
Daejeon
Boehringer Ingelheim Investigational Site 17
Daejeon
Boehringer Ingelheim Investigational Site 18
Daejeon
Boehringer Ingelheim Investigational Site 19
Daejeon
Boehringer Ingelheim Investigational Site 20
Gangwondo
Boehringer Ingelheim Investigational Site 21
Gangwondo
Boehringer Ingelheim Investigational Site 22
Gangwondo
Boehringer Ingelheim Investigational Site 23
Gangwondo
Boehringer Ingelheim Investigational Site 24
Gyeonggido
Boehringer Ingelheim Investigational Site 25
Gyeonggido
Boehringer Ingelheim Investigational Site 26
Gyeonggido
Boehringer Ingelheim Investigational Site 27
Gyeonggido
Boehringer Ingelheim Investigational Site 28
Gyeonggido
Boehringer Ingelheim Investigational Site 29
Gyeonggido
Boehringer Ingelheim Investigational Site 30
Gyeonggido
Boehringer Ingelheim Investigational Site 31
Gyeonggido
Boehringer Ingelheim Investigational Site 32
Gyeonggido
Boehringer Ingelheim Investigational Site 70
Gyeongnam
Boehringer Ingelheim Investigational Site 71
Gyeongnam
Boehringer Ingelheim Investigational Site 33
Incheon
Boehringer Ingelheim Investigational Site 34
Incheon
Boehringer Ingelheim Investigational Site 35
Incheon
Boehringer Ingelheim Investigational Site 36
Incheon
Boehringer Ingelheim Investigational Site 37
Jeonbuk
Boehringer Ingelheim Investigational Site 38
Jeonbuk
Boehringer Ingelheim Investigational Site 39
Jeonbuk
Boehringer Ingelheim Investigational Site 40
Jeonnam
Boehringer Ingelheim Investigational Site 41
Jeonnam
Boehringer Ingelheim Investigational Site 42
Jeonnam
Boehringer Ingelheim Investigational Site 43
Jeonnam
Boehringer Ingelheim Investigational Site 44
Jeonnam
Boehringer Ingelheim Investigational Site 45
Jeonnam
Boehringer Ingelheim Investigational Site 46
Jeonnam
Boehringer Ingelheim Investigational Site 69
Jungbuk
Boehringer Ingelheim Investigational Site 47
Seoul
Boehringer Ingelheim Investigational Site 48
Seoul
Boehringer Ingelheim Investigational Site 49
Seoul
Boehringer Ingelheim Investigational Site 50
Seoul
Boehringer Ingelheim Investigational Site 51
Seoul
Boehringer Ingelheim Investigational Site 52
Seoul
Boehringer Ingelheim Investigational Site 53
Seoul
Boehringer Ingelheim Investigational Site 54
Seoul
Boehringer Ingelheim Investigational Site 55
Seoul
Boehringer Ingelheim Investigational Site 56
Seoul
Boehringer Ingelheim Investigational Site 57
Seoul
Boehringer Ingelheim Investigational Site 58
Seoul
Boehringer Ingelheim Investigational Site 59
Seoul
Boehringer Ingelheim Investigational Site 60
Seoul
Boehringer Ingelheim Investigational Site 61
Seoul
Boehringer Ingelheim Investigational Site 62
Seoul
Boehringer Ingelheim Investigational Site 63
Seoul
Boehringer Ingelheim Investigational Site 64
Seoul
Boehringer Ingelheim Investigational Site 65
Seoul
Boehringer Ingelheim Investigational Site 66
Seoul
Boehringer Ingelheim Investigational Site 67
Seoul
Boehringer Ingelheim Investigational Site 68
Ulsan

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

Study Design:

Conditions: Pulmonary Disease, Chronic Obstructive
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Dec 2007

First posted21 Feb 2008 (estimated)
Study startMar 2004
Primary completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 3,008 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620516
Sponsor's protocol ID: 205.337
Status last verified: Nov 2013
First submitted: 4 Feb 2008
Last updated: 19 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00620516
Acronym / sponsor ID: 205.337
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 3,008 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: Dec 2007 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

Study design

Time perspective: Prospective

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 3227

Key inclusion criteria (1 listed)

Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

71 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 71 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.