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To evaluate the effect of Mucomyst nebulizer therapy on improvement in symptoms and quality of life in COPD patients with difficulty of expectoration.
In this non-interventional observational study, treatment for individual subjects is determined by the investigator according to the status of individual subjects in routine clinical practice. In this circumstance, doses for each drug product will not be specified in the protocol but will be determined as appropriate by the investigator with the product label and the subject's medical condition taken into consideration.
Primary objective To evaluate the effect of Mucomyst on improvement in difficulty of expectoration symptoms in COPD patients with difficulty of expectoration.
Secondary objective To evaluate the effect of Mucomyst on improvement in quality of life and safety in COPD patients with difficulty of expectoration.
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CAT | Change from baseline in CAT phlegm score at Week 12 | at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CAT | Change from baseline in CAT phlegm score at Weeks 4 and 8 | at Weeks 4 and 8 |
| Change from baseline in CAT | Change from baseline in CAT total score and sub-scale score at Weeks 4, 8, and 12 |
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Inclusion Criteria:
Exclusion criteria
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Chronic Obstructive Pulmonary Disease (COPD) patients with Difficulty of Expectoration. Total 100 subjects
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| Name | Affiliation | Role |
|---|---|---|
| MyungSook Hong | MOG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Konkuk University medical center | Seoul | South Korea |
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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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| at Weeks 4, 8,and 12 |
| Change from baseline in SGRQ-C | Change from baseline in St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at Weeks 4, 8, and 12 | at Weeks 4, 8, and 12 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |