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- Title
The effect of nebulized N-acetylcysteine on the phlegm of chronic obstructive pulmonary disease: the NEWEST study.
- Authors
Rhee, Chin Kook; Lim, Seong Yong; Lee, Won-Yeon; Jung, Ji Ye; Park, Yong Bum; Lee, Chang Youl; Hwang, Yong Il; Song, Jin Woo; Choi, Won-Il; Yoo, Kwang Ha; Kim, Ki Uk; Kim, Yu-Il; Kim, Tae-Hyung; Park, Seong Ju; Shin, Kyeong-Cheol; Um, Soo-Jung; Yoon, Hyoung Kyu; Lee, Ho Sung; Kim, Deog Kyeom; Leem, Ah Young
- 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.
- Subjects
CHRONIC obstructive pulmonary disease; DRUG side effects; PATIENT satisfaction; CHRONIC bronchitis; VITAL capacity (Respiration)
- Publication
BMC Pulmonary Medicine, 2024, Vol 24, Issue 1, p1
- ISSN
1471-2466
- Publication type
Article
- DOI
10.1186/s12890-024-03243-y