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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102305
• Other study ID #: BR-NAC-OS-402
• Status: Completed
• Start date: September 9, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: December 2022
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the effect of Mucomyst nebulizer therapy on improvement in symptoms and quality of life in COPD patients with difficulty of expectoration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 29, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Korea, Republic of	The Konkuk University medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CAT	Change from baseline in CAT phlegm score at Week 12	at Week 12
Secondary	Change from baseline in CAT	Change from baseline in CAT phlegm score at Weeks 4 and 8	at Weeks 4 and 8
Secondary	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
Secondary	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