A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Prospective, Observational Study to Evaluate the Effectiveness of N-acetylcysteine (NAC) Nebulizer Therapy (Mucomyst Solution) in COPD With Difficulty of Expectoration

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: man and woman at the age of ≥40 years old Diagnosed with COPD within the past 1 year based on pulmonary function test (post bronchodilator FEV1/FVC<0.7) COPD Assessment Test (CAT) phlegm score ≥2 Smoking history ≥10 pack-years* (*Pack-year: number of packs of cigarettes smoked per day X number of years the individual has smoked) Patient who is to be treated with Mucomyst nebulizer therapy to alleviate difficulty of expectoration symptoms Voluntary written informed consent to study participation and to use of personal information for this study Exclusion criteria History of hypersensitivity reactions to any of the components of NAC or contraindicated to NAC therapy according to the product label Treated with Mucomyst within the past 4 weeks Newly treated with 'drugs for the alleviation of expectoration symptoms (antitussives/expectorants)' or dose changed for ongoing therapy within the past 4 weeks Pregnant and lactating woman Participating in another trial with investigational product treatment at the time of enrollment to the present study Ineligible for study participation in the opinion of the investigator

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 |
| --- | --- | --- |
| Change from baseline in CAT | Change from baseline in CAT phlegm score at Week 12 | at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |