Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
| NCT number | NCT00615992 |
| Other study ID # | 205.398 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 24, 2008 |
| Last updated | January 13, 2016 |
| Start date | April 2007 |
| Verified date | January 2016 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Federal Office for Safety in Health Care |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 754 |
| Est. completion date | |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with suspected chronic obstructive pulmonary disease (COPD) - 3 or more positive answers in COPD questionnaire - Age over 40 years Exclusion Criteria: - Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics - Patient treated with Spiriva in the past year - Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| Austria | Boehringer Ingelheim Investigational Site | Admont | |
| Austria | Boehringer Ingelheim Investigational Site | 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 | |
| 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 | Haid bei Ansfelden | |
| 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 132 | |
| 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 | |
| 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 | Salzburg | |
| Austria | Boehringer Ingelheim Investigational Site | Schwechat | |
| Austria | Boehringer Ingelheim Investigational Site | St. Johann | |
| Austria | Boehringer Ingelheim Investigational Site | St. Stefan o Stainz | |
| Austria | Boehringer Ingelheim Investigational Site | St. Valentin | |
| Austria | Boehringer Ingelheim Investigational Site | St. Veit Glan | |
| 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 | Vöcklabruck | |
| Austria | Boehringer Ingelheim Investigational Site | Wallern an der Trattnach | |
| Austria | Boehringer Ingelheim Investigational Site | Weißtrach | |
| Austria | Boehringer Ingelheim Investigational Site | Weiz | |
| Austria | Boehringer Ingelheim Investigational Site | Wien | |
| Austria | Boehringer Ingelheim Investigational Site | Wilhelmsburg | |
| Austria | Boehringer Ingelheim Investigational Site | Wolfsberg | |
| Austria | Boehringer Ingelheim Investigational Site | Wolkersdorf |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) | No |
| 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) | Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
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