Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

Study Overview
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Brief Summary
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The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.

Official Title
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Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

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 confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005). Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication. Tiotropium bromide naïve patients. Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label. Exclusion criteria: Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert). Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients<br> | Drug: Tiotropium<br>* Tiotropium 18 mcg HandiHaler once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment | The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient? | Baseline and 8 weeks | 
| Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment | FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible | Baseline and 8 weeks | 
| Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment | FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (<80%, often  45%). | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment | The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient? | Baseline and 8 weeks | 
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment | The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient? | Baseline and 8 weeks | 
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment | The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient? | Baseline and 8 weeks | 
| Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs | The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient? | Baseline and 8 weeks | 
| Percentage of Participants Which Had a Reduction of Concomitant Drug Use | The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit. | 8 weeks |