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OpenTrials
Completed

NCT Number: NCT05102305

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Konkuk University medical center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline in CAT

    Time frame: at Week 12

    Change from baseline in CAT phlegm score at Week 12

Secondary outcomes

  1. Change from baseline in CAT

    Time frame: at Weeks 4 and 8

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

  2. Change from baseline in CAT

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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