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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Tiotropium 18 mcg HandiHaler once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 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 | 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%). | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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?" |
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Inclusion criteria:
Exclusion criteria:
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COPD
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Chan Wha | Taiwan | ||||
| Boehringer Ingelheim Investigational Site |
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A total of 2,031 patients were enrolled between Jan-11-2008 to Mar-24-2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva 18µg With HandiHaler Device on COPD Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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?" | 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?" | 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?" | 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. | 8 weeks |
| Chiayi City |
| Taiwan |
| Boehringer Ingelheim Investigational Site | Hsinchu | Taiwan |
| Boehringer Ingelheim Investigational Site | Hwa Lian | Taiwan |
| Boehringer Ingelheim Investigational Site 1 | Kaohsiung City | Taiwan |
| Boehringer Ingelheim Investigational Site 2 | Kaohsiung City | Taiwan |
| Boehringer Ingelheim Investigational Site 3 | Kaohsiung City | Taiwan |
| Boehringer Ingelheim Investigational Site 1 | Taichung | Taiwan |
| Boehringer Ingelheim Investigational Site 2 | Taichung | Taiwan |
| Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| Boehringer Ingelheim Investigational Site 1 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site 2 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site 3 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site 4 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site 5 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site 6 | Taipiei | Taiwan |
| Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva 18µg With HandiHaler Device on COPD Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The number is different than the overall number of baseline participants because some of the CRF have lost during the follow up of the patient. | Mean | Standard Deviation | Year |
| |||||||||||||||||||||
| Gender | The number is different than the overall number of baseline participants because some of the CRF have lost during the follow up of the patient. | Number | Participants |
| ||||||||||||||||||||||
| Weight | The number is different than the overall number of baseline participants because some of the CRF have lost during the follow up of the patient. | Mean | Standard Deviation | kg |
| |||||||||||||||||||||
| Height | The number is different than the overall number of baseline participants because some of the CRF have lost during the follow up of the patient. | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 8 weeks |
|
|
| |||||||||||||||||||||||||
| Primary | 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 | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | liter per second | Baseline and 8 weeks |
|
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| Primary | 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%). | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Ratio | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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?" | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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?" | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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?" | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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?" | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population. | Posted | Number | Percentage of Participants | 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spiriva 18µg With HandiHaler Device on COPD Patients | 16 | 2,031 | 0 | 2,031 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA v11.1 | Systematic Assessment |
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| Death | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA v11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v11.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Systematic Assessment |
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| Chronic Obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Systematic Assessment |
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| Respiratory therapy | Surgical and medical procedures | MedDRA v11.1 | Systematic Assessment |
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| Infarction | Vascular disorders | MedDRA v11.1 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA v11.1 | Systematic Assessment |
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| Cynosis | Cardiac disorders | MedDRA v11.1 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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