Pulmonary Disease, Chronic ObstructiveNCT00624377
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 17 sites in Taiwan.
Trial summary
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium
- How many people
- 2,031 participants
- Where
- 17 sitesTaiwan
- Study dates
- Dec 2007to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD
Who may be able to join
- Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
- Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
- Tiotropium bromide naïve patients.
- Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.
Who cannot join
- Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
- Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Taiwan17 sites
Boehringer Ingelheim Investigational Site
Chan Wha
Boehringer Ingelheim Investigational Site
Chiayi City
Boehringer Ingelheim Investigational Site
Hsinchu
Boehringer Ingelheim Investigational Site
Hwa Lian
Boehringer Ingelheim Investigational Site 1
Kaohsiung City
Boehringer Ingelheim Investigational Site 2
Kaohsiung City
Boehringer Ingelheim Investigational Site 3
Kaohsiung City
Boehringer Ingelheim Investigational Site 1
Taichung
Boehringer Ingelheim Investigational Site 2
Taichung
Boehringer Ingelheim Investigational Site
Tainan
Boehringer Ingelheim Investigational Site 1
Taipiei
Boehringer Ingelheim Investigational Site 2
Taipiei
Boehringer Ingelheim Investigational Site 3
Taipiei
Boehringer Ingelheim Investigational Site 4
Taipiei
Boehringer Ingelheim Investigational Site 5
Taipiei
Boehringer Ingelheim Investigational Site 6
Taipiei
Boehringer Ingelheim Investigational Site
Taoyuan
About this study
Official title: Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
Tiotropium 18 mcg HandiHaler once daily
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Measured: Baseline and 8 weeks
Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment
FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible
Measured: Baseline and 8 weeks
Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment
FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (<80%, often ~45%).
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Measured: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Measured: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Measured: Baseline and 8 weeks
Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Measured: Baseline and 8 weeks
Percentage of Participants Which Had a Reduction of Concomitant Drug Use
The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624377
- Sponsor's protocol ID
- 205.399
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2008
- Last updated
- 28 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
- ClinicalTrials.gov ID
- NCT00624377
- Acronym / sponsor ID
- 205.399
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,031 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 15 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Drug: Tiotropium |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD
Key inclusion criteria (4 listed)
- Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
- Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
- Tiotropium bromide naïve patients.
- Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.
Key exclusion criteria (2 listed)
- Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
- Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumTiotropium 18 mcg HandiHaler once daily | Drug | COPD patients |
Primary outcome
Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment
Time frame: Baseline and 8 weeks
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible
Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (<80%, often ~45%).
5 secondary outcomes
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment
Time frame: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment
Time frame: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment
Time frame: Baseline and 8 weeks
Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs
Time frame: Baseline and 8 weeks
Percentage of Participants Which Had a Reduction of Concomitant Drug Use
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
17 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 17 sites in Taiwan.
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 4 inclusion and 2 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Taiwan. 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?
Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment (time frame: Baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2014.