Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |