Status:
COMPLETED
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
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 ch...
Eligibility Criteria
Inclusion
- Patients with suspected chronic obstructive pulmonary disease (COPD)
- 3 or more positive answers in COPD questionnaire
- Age over 40 years
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT00615992
Start Date
April 1 2007
Last Update
February 8 2016
Active Locations (73)
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1
Boehringer Ingelheim Investigational Site
Admont, Austria
2
Boehringer Ingelheim Investigational Site
Afritz Am See, Austria
3
Boehringer Ingelheim Investigational Site
Altenmarkt, Austria
4
Boehringer Ingelheim Investigational Site
Altmünster, Austria