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Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Obstructive Respiratory Tract Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berotec® N 100 µg Metered-dose Inhaler | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg | After 3 weeks of first drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessment of efficacy on a 4-point scale | Up to 3 weeks after first drug administration | |
| Patient assessment of efficacy on a 4-point scale | Up to 3 weeks after first drug administration |
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Inclusion Criteria:
Exclusion Criteria:
• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler
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Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| Patient assessment of tolerability on a 4-point scale | Up to 3 weeks after first drug administration |
| Investigator comparative overall assessment on a 4-point scale | After 3 weeks of first drug administration |
| Number of patients with adverse drug reactions | Up to 3 weeks after first drug administration |
| Number of patients who changed the concomitant medication | Up to 3 weeks after first drug administration |
| Number of patients who continued treatment | Up to 3 weeks after first drug administration |
| Number of patients who premature withdrew from the treatment | Up to 3 weeks after first drug administration |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |