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

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05102305
Collaborator
(none)
100
Enrollment
1
Location
15.7
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Sep 9, 2021
    Anticipated Primary Completion Date :
    Aug 16, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in CAT [at Week 12]

      Change from baseline in CAT phlegm score at Week 12

    Secondary Outcome Measures

    1. Change from baseline in CAT [at Weeks 4 and 8]

      Change from baseline in CAT phlegm score at Weeks 4 and 8

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Konkuk University medical center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT05102305
    Other Study ID Numbers:
    • BR-NAC-OS-402
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Nov 1, 2021