Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

Study Overview
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Brief Summary
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Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available. Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).

Detailed Description
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Study Design: observational

Official Title
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Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion criteria COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines Exclusion criteria Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Treatment With Tiotropium According to Physician's Assessment | Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful | 6 - 12 weeks | 
| Assessment of Efficacy According to Physician | Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined | 6 - 12 weeks | 
| Assessment of Tolerability According to Physician | Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined | 6 - 12 weeks | 
| Assessment of Efficacy According to Patient | patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing) | 6 - 12 weeks | 
| Assessment of Tolerability According to Patient | Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing) | 6 - 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Evaluation at Visit 1 | Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores Poor (1, 2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8) prior to treatment with Spiriva. | 0 weeks | 
| Physician's Global Evaluation at Visit 2 | Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva. | after 6 - 12 weeks |