Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

Study Overview
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Brief Summary
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The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.

Detailed Description
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Study Design:

Official Title
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Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline. Patients over 40 years old Exclusion Criteria: 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.,creatinin 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® China package insert Patients with signed informed consent of any other study

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks) | 0 weeks (Visit 1) and 8 weeks (Visit 3) | 
| Patient Tolerability Assessment at Visit 3 | Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good | 8 weeks (Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks) | 2 weeks (Visit 2 and 8 weeks (Visit 3) | 
| Physician Tolerability Assessment at Visit 3 | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8) | 8 weeks (Visit 3) |