Clinical Trial

. 2024 Sep 2;24(1):434.

doi: 10.1186/s12890-024-03243-y.

The effect of nebulized N-acetylcysteine on the phlegm of chronic obstructive pulmonary disease: the NEWEST study

Chin Kook Rhee¹, Seong Yong Lim², Won-Yeon Lee³, Ji Ye Jung⁴, Yong Bum Park⁵, Chang Youl Lee⁶, Yong Il Hwang⁷, Jin Woo Song⁸, Won-Il Choi⁹, Kwang Ha Yoo¹⁰, Ki Uk Kim¹¹, Yu-Il Kim¹², Tae-Hyung Kim¹³, Seong Ju Park¹⁴, Kyeong-Cheol Shin¹⁵, Soo-Jung Um¹⁶, Hyoung Kyu Yoon¹⁷, Ho Sung Lee¹⁸, Deog Kyeom Kim¹⁹, Ah Young Leem⁴; Korean Pulmonary Rehabilitation Study Group

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
² Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
³ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.
⁴ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
⁵ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, South Korea.
⁶ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, South Korea.
⁷ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
⁸ Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
⁹ Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.
¹⁰ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, 120 Neungdong-Ro, Gwangjin-Gu, Seoul, 05029, South Korea. khyou@kuh.ac.kr.
¹¹ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University School of Medicine, Busan, South Korea.
¹² Division of Pulmonary Medicine, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, South Korea.
¹³ Division of Pulmonary and Critical Care Medicine. Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.
¹⁴ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, South Korea.
¹⁵ Division of Pulmonology and Allergy, Department of Internal Medicine, Regional Center for Respiratory Disease, College of Medicine, Yeungnam University, Daegu, South Korea.
¹⁶ Division of Respiratory Medicine, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, South Korea.
¹⁷ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
¹⁸ Division of Respiratory Medicine, Soon Chun Hyang University Hospital Cheonan, Cheonan, South Korea.
¹⁹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.

PMID: 39223526
PMCID: PMC11369990
DOI: 10.1186/s12890-024-03243-y

Clinical Trial

The effect of nebulized N-acetylcysteine on the phlegm of chronic obstructive pulmonary disease: the NEWEST study

Chin Kook Rhee et al. BMC Pulm Med. 2024.

. 2024 Sep 2;24(1):434.

doi: 10.1186/s12890-024-03243-y.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
² Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
³ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.
⁴ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
⁵ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, South Korea.
⁶ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, South Korea.
⁷ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
⁸ Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
⁹ Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.
¹⁰ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, 120 Neungdong-Ro, Gwangjin-Gu, Seoul, 05029, South Korea. khyou@kuh.ac.kr.
¹¹ Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University School of Medicine, Busan, South Korea.
¹² Division of Pulmonary Medicine, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, South Korea.
¹³ Division of Pulmonary and Critical Care Medicine. Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.
¹⁴ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, South Korea.
¹⁵ Division of Pulmonology and Allergy, Department of Internal Medicine, Regional Center for Respiratory Disease, College of Medicine, Yeungnam University, Daegu, South Korea.
¹⁶ Division of Respiratory Medicine, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, South Korea.
¹⁷ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
¹⁸ Division of Respiratory Medicine, Soon Chun Hyang University Hospital Cheonan, Cheonan, South Korea.
¹⁹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.

PMID: 39223526
PMCID: PMC11369990
DOI: 10.1186/s12890-024-03243-y

Abstract

Background: Phlegm is prevalent symptom in patients with chronic obstructive pulmonary disease (COPD). Few studies have investigated the effectiveness of N-acetylcysteine (NAC) nebulizer therapy in COPD patients. We evaluated the effect of nebulized NAC on the improvement of phlegm symptom in COPD patients.

Methods: This was a 12-week, prospective, single-arm, open-label, phase IV multi-center trial (NCT05102305, Registration Date: 20-October-2021). We enrolled patients aged ≥ 40 years with post bronchodilator forced expiratory volume in one second/forced vital capacity (FEV₁/FVC) < 0.7 and COPD assessment test (CAT) phlegm score ≥ 2; the patients were current or ex-smoker with smoking pack-years ≥ 10. The primary endpoint was to determine the change in CAT phlegm score at 12 weeks compared to the baseline. Patients were assessed at baseline, 4, 8, and 12 weeks of treatment using the CAT score.

Results: In total, 100 COPD patients were enrolled from 10 hospitals. The mean age of the patients was 71.42 ± 8.20 years, with 19.78% being current-smokers and 80.22% being ex-smokers. The mean smoking pack-years was 40.32 ± 35.18. The mean FVC, FEV₁, and FEV₁/FVC were 3.94 L (75.44%), 2.22 L (58.50%), and 0.53, respectively. The CAT phlegm score at baseline was 3.47 ± 1.06, whereas after 12 weeks of nebulized NAC it significantly decreased to 2.62 ± 1.30 (p < 0.01). More than half (53.5%) of the patients expressed satisfaction with the effects of nebulized NAC therapy. Adverse events occurred in 8 (8.0%) patients. Notably, no serious adverse drug reactions were reported.

Conclusion: In this study, we have established the effectiveness and safety of nebulized NAC over 12 weeks.

Keywords: Chronic bronchitis; Chronic obstructive pulmonary disease; N-acetylcysteine; Nebulizer.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Fig. 1**
Study design. PFT = pulmonary function test, CAT = COPD assessment test, SGRQ-C = St. George’s respiratory questionnaire for COPD patients, ADR = adverse drug reaction

**Fig. 2**
Change in CAT score after 12 weeks of nebulized NAC (n = 91). ^**p < 0.01. CAT = COPD assessment test, NAC = N-acetylcysteine

See this image and copyright information in PMC

References

1. Sin DD. Chronic obstructive pulmonary disease and the airway microbiome: what respirologists need to know. Tuberc Respir Dis. 2023;86(3):166–75.10.4046/trd.2023.0015 - DOI - PMC - PubMed
1. Jo YS. Long-term outcome of chronic obstructive pulmonary disease: a review. Tuberc Respir Dis. 2022;85(4):289–301.10.4046/trd.2022.0074 - DOI - PMC - PubMed
1. Kesimer M, Ford AA, Ceppe A, Radicioni G, Cao R, Davis CW, Doerschuk CM, Alexis NE, Anderson WH, Henderson AG, et al. Airway mucin concentration as a marker of chronic bronchitis. N Engl J Med. 2017;377(10):911–22. 10.1056/NEJMoa1701632 - DOI - PMC - PubMed
1. Hogg JC. Pathophysiology of airflow limitation in chronic obstructive pulmonary disease. Lancet. 2004;364(9435):709–21. 10.1016/S0140-6736(04)16900-6 - DOI - PubMed
1. Kim WD. Phenotype of chronic obstructive pulmonary disease based on computed tomography-defined underlying pathology. Tuberc Respir Dis. 2022;85(4):302–12.10.4046/trd.2022.0029 - DOI - PMC - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

LinkOut - more resources

Full Text Sources
- PubMed Central

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

The effect of nebulized N-acetylcysteine on the phlegm of chronic obstructive pulmonary disease: the NEWEST study

Affiliations

The effect of nebulized N-acetylcysteine on the phlegm of chronic obstructive pulmonary disease: the NEWEST study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources