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The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva | The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva | The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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primary care
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Admont | Austria | ||||
| Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva® (Tiotropium Bromide) | Tiotropium bromide 18μg inhalation capsules once-daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Global Assessment of Efficacy by Patient |
Rating scale ranging from very good (best value) to not satisfactory (worst value) |
| Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
| Global Assessment of Tolerability by Patient | Rating scale ranging from very good (best value) to not satisfactory (worst value) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
| Global Assessment of Efficacy by Physician | Rating scale ranging from very good (best value) to not satisfactory (worst value) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
| Global Assessment of Tolerability by Physician | Rating scale ranging from very good (best value) to not satisfactory (worst value) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
| Afritz Am See |
| Austria |
| Boehringer Ingelheim Investigational Site | Altenmarkt | Austria |
| Boehringer Ingelheim Investigational Site | Altmünster | Austria |
| Boehringer Ingelheim Investigational Site | Bad Gleichenberg | Austria |
| Boehringer Ingelheim Investigational Site | Bad Goisern am Hallstättersee | Austria |
| Boehringer Ingelheim Investigational Site | Bad Hall | Austria |
| Boehringer Ingelheim Investigational Site | Bad Häring | Austria |
| Boehringer Ingelheim Investigational Site | Bleiburg | Austria |
| Boehringer Ingelheim Investigational Site | Bludenz | Austria |
| Boehringer Ingelheim Investigational Site | Brixlegg | Austria |
| Boehringer Ingelheim Investigational Site | Drasenhofen | Austria |
| Boehringer Ingelheim Investigational Site | Enns | Austria |
| Boehringer Ingelheim Investigational Site | Fohnsdorf | Austria |
| Boehringer Ingelheim Investigational Site | Gänserndorf | Austria |
| Boehringer Ingelheim Investigational Site | Gmunden | Austria |
| Boehringer Ingelheim Investigational Site | Grafenstein | Austria |
| Boehringer Ingelheim Investigational Site | Graz | Austria |
| Boehringer Ingelheim Investigational Site | Grünbach | Austria |
| Boehringer Ingelheim Investigational Site | Gunskirchen | Austria |
| Boehringer Ingelheim Investigational Site | Gutenstein | Austria |
| Boehringer Ingelheim Investigational Site | Haid | Austria |
| Boehringer Ingelheim Investigational Site | Hainburg/a.d. Donau | Austria |
| Boehringer Ingelheim Investigational Site | Herzogenburg | Austria |
| Boehringer Ingelheim Investigational Site | Hürm | Austria |
| Boehringer Ingelheim Investigational Site | Innsbruck | Austria |
| Boehringer Ingelheim Investigational Site | Jenbach | Austria |
| Boehringer Ingelheim Investigational Site | Judenburg | Austria |
| Boehringer Ingelheim Investigational Site | Kindberg | Austria |
| Boehringer Ingelheim Investigational Site | Kirchberg Wechsel | Austria |
| Boehringer Ingelheim Investigational Site | Klagenfurt | Austria |
| Boehringer Ingelheim Investigational Site | Klein-Pöchlarn | Austria |
| Boehringer Ingelheim Investigational Site | Knittelfeld | Austria |
| Boehringer Ingelheim Investigational Site | Königswiesen | Austria |
| Boehringer Ingelheim Investigational Site | Kuchl | Austria |
| Boehringer Ingelheim Investigational Site | Langenrohr | Austria |
| Boehringer Ingelheim Investigational Site | Lebring | Austria |
| Boehringer Ingelheim Investigational Site | Leobersdorf | Austria |
| Boehringer Ingelheim Investigational Site | Linz | Austria |
| Boehringer Ingelheim Investigational Site | Lustenau | Austria |
| Boehringer Ingelheim Investigational Site | Mank | Austria |
| Boehringer Ingelheim Investigational Site | Mödling | Austria |
| Boehringer Ingelheim Investigational Site | Neuberg/Mürz | Austria |
| Boehringer Ingelheim Investigational Site | Neumarkt a.W. | Austria |
| Boehringer Ingelheim Investigational Site | Neunkirchen | Austria |
| Boehringer Ingelheim Investigational Site | Niederhollabrunn | Austria |
| Boehringer Ingelheim Investigational Site | Oberschützen | Austria |
| Boehringer Ingelheim Investigational Site | Ollersdorf | Austria |
| Boehringer Ingelheim Investigational Site | Passail | Austria |
| Boehringer Ingelheim Investigational Site | Peesen | Austria |
| Boehringer Ingelheim Investigational Site | Pfarrkirchen bei Bad Hall | Austria |
| Boehringer Ingelheim Investigational Site | Pichl bei Wels | Austria |
| Boehringer Ingelheim Investigational Site | Pischeldorf | Austria |
| Boehringer Ingelheim Investigational Site | Rattenberg | Austria |
| Boehringer Ingelheim Investigational Site | Saint Johann | Austria |
| Boehringer Ingelheim Investigational Site | Saint Stefan O Stainz | Austria |
| Boehringer Ingelheim Investigational Site | Saint Veit Glan | Austria |
| Boehringer Ingelheim Investigational Site | Salzburg | Austria |
| Boehringer Ingelheim Investigational Site | Sankt Valentin | Austria |
| Boehringer Ingelheim Investigational Site | Schwechat | Austria |
| Boehringer Ingelheim Investigational Site | St.Georgen/Judenburg 12 | Austria |
| Boehringer Ingelheim Investigational Site | Stainach | Austria |
| Boehringer Ingelheim Investigational Site | Stasshof | Austria |
| Boehringer Ingelheim Investigational Site | Traismauer | Austria |
| Boehringer Ingelheim Investigational Site | Tulln | Austria |
| Boehringer Ingelheim Investigational Site | Vienna | Austria |
| Boehringer Ingelheim Investigational Site | Vöcklabruck | Austria |
| Boehringer Ingelheim Investigational Site | Wallern an der Trattnach | Austria |
| Boehringer Ingelheim Investigational Site | Weiz | Austria |
| Boehringer Ingelheim Investigational Site | Weißtrach | Austria |
| Boehringer Ingelheim Investigational Site | Wilhelmsburg | Austria |
| Boehringer Ingelheim Investigational Site | Wolfsberg | Austria |
| Boehringer Ingelheim Investigational Site | Wolkersdorf | Austria |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva® (Tiotropium Bromide) | Tiotropium bromide 18μg inhalation capsules once-daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | 687 eligible for efficacy analysis (complete data set available) Throughout this report, the discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. Number of Participant in this summary is "number of patients used for analysis". | Number | participants |
|
| 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 | Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva | The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Mean | Standard Deviation | points on a scale | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
|
| |||||||||||||||||||||||||
| Secondary | Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva | The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Mean | Standard Deviation | points on a scale | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Global Assessment of Efficacy by Patient | Rating scale ranging from very good (best value) to not satisfactory (worst value) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Number | Participants | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Global Assessment of Tolerability by Patient | Rating scale ranging from very good (best value) to not satisfactory (worst value) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Number | Participants | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Global Assessment of Efficacy by Physician | Rating scale ranging from very good (best value) to not satisfactory (worst value) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Number | Participants | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Global Assessment of Tolerability by Physician | Rating scale ranging from very good (best value) to not satisfactory (worst value) | The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data. | Posted | Number | Participants | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) |
|
|
4 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® (Tiotropium Bromide) | Tiotropium bromide 18μg inhalation capsules once-daily | 0 | 754 | 0 | 754 |
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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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