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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05102305
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-09
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Primary Completion: 2022-08-16
• Study Completion: 2022-11-29
• Status Verified: 2022-12
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. man and woman at the age of ≥40 years old
2. Diagnosed with COPD within the past 1 year based on pulmonary function test (post bronchodilator FEV1/FVC<0.7)
3. COPD Assessment Test (CAT) phlegm score ≥2
4. Smoking history ≥10 pack-years* (*Pack-year: number of packs of cigarettes smoked per day X number of years the individual has smoked)
5. Patient who is to be treated with Mucomyst nebulizer therapy to alleviate difficulty of expectoration symptoms
6. Voluntary written informed consent to study participation and to use of personal information for this study

Exclusion criteria

1. History of hypersensitivity reactions to any of the components of NAC or contraindicated to NAC therapy according to the product label
2. Treated with Mucomyst within the past 4 weeks
3. Newly treated with 'drugs for the alleviation of expectoration symptoms (antitussives/expectorants)' or dose changed for ongoing therapy within the past 4 weeks
4. Pregnant and lactating woman
5. Participating in another trial with investigational product treatment at the time of enrollment to the present study
6. Ineligible for study participation in the opinion of the investigator

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in CAT	at Week 12	Change from baseline in CAT phlegm score at Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in CAT	at Weeks 4, 8,and 12	Change from baseline in CAT total score and sub-scale score at Weeks 4, 8, and 12
Change from baseline in SGRQ-C	at Weeks 4, 8, and 12	Change from baseline in St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at Weeks 4, 8, and 12

Trial Locations

Locations (1)

The Konkuk University medical center; 🇰🇷 Seoul, Korea, Republic of