Drug Use Survey of RESPIMAT in Patients With COPD

Study Overview
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Brief Summary
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To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.

Official Title
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Long Time Survey of RESPIMAT in Daily Clinical Use

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat. Exclusion criteria: There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.

Ages Eligible for Study
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Minimum Age: 15 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 |
| --- | --- |
| Treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | The number of patient with any AEs, patients with drug-related AEs | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician. | Week 52 | 
| Forced Expiratory Volume in One Second (FEV1) | FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated. | Week 0 and Week 52 | 
| Cough Frequency | Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently. | Week 0 and Week 52 | 
| Amount of Sputum | Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much. | Week 0 and Week 52 | 
| Shortness of Breath | Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day. | Week 0 and Week 52 | 
| Nocturnal Sleep | Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night. | Week 0 and Week 52 |