PMID- 36344940 OWN - NLM STAT- MEDLINE DCOM- 20221109 LR - 20221111 IS - 1471-2466 (Electronic) IS - 1471-2466 (Linking) VI - 22 IP - 1 DP - 2022 Nov 7 TI - The effect of N-acetylcysteine in patients with non-cystic fibrosis bronchiectasis (NINCFB): study protocol for a multicentre, double-blind, randomised, placebo-controlled trial. PG - 401 LID - 10.1186/s12890-022-02202-9 [doi] LID - 401 AB - BACKGROUND: N-acetylcysteine (NAC), which is specifically involved in airway mucus clearance and antioxidation, is recommended by the treatment guideline for non-cystic fibrosis bronchiectasis (NCFB). However, there is little clinical evidence of its long-term efficacy concerning quality of life (QoL) and exacerbation in patients with NCFB. In addition, the influences of NAC on airway bacterial colonization, chronic inflammation and oxidative stress in NCFB are also unclear. METHODS: NINCFB is a prospective, multicentre, double-blind, randomised, placebo-controlled trial that will recruit 119 patients with NCFB and randomly divide them into an NAC group (n = 79) and a control group (n = 40). Participants in the NAC group will receive 600 mg oral NAC twice daily for 52 weeks, while patients in the control group will receive 600 mg placebo twice daily for 52 weeks. The information at baseline will be collected once participants are enrolled. The primary endpoints are the changes in St George's Respiratory Questionnaire scores and the number of exacerbations in 52 weeks. The secondary endpoints are the 16S rRNA of sputum and the levels of inflammatory factors and oxidative stressors in sputum and serum. Other data related to radiography, lung function tests, number of oral and/or intravenous antibiotic therapies and adverse events (AEs) will also be analysed. Further subgroup analysis distinguished by the severity of disease, severity of lung function, airway bacterial colonization and exacerbation frequency will be performed. DISCUSSION: The objective of this study is to determine the long-term efficacy of NAC on QoL and exacerbation of NCFB and to explore the effectiveness of NAC for antibiosis, anti-inflammation and antioxidation in NCFB. The study results will provide high-quality clinical proof for the revision and optimization of treatment guidelines and for expert consensus on NCFB treatment. TRIAL REGISTRATION: The trial was registered on the Chinese Clinical Trial Register at April 11, 2020 ( chictr.org.cn , ChiCTR2000031817). CI - (c) 2022. The Author(s). FAU - Liao, Yue AU - Liao Y AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Wu, Yanqiu AU - Wu Y AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Zi, Kai AU - Zi K AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Shen, Yongchun AU - Shen Y AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Wang, Tao AU - Wang T AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Qin, Jiangyue AU - Qin J AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Chen, Lei AU - Chen L AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. FAU - Chen, Mei AU - Chen M AD - Department of Respiratory, Chengdu Fifth People's Hospital, Chengdu, China. FAU - Liu, Lin AU - Liu L AD - Department of Respiratory and Critical Care Medicine, 363 Hospital, Chengdu, China. FAU - Li, Weiming AU - Li W AD - Department of Respiratory Medicine, Chengdu Sixth People's Hospital, Chengdu, China. FAU - Zhou, Hui AU - Zhou H AD - Department of Respiratory, Chengdu University Affiliated Hospital, Chengdu, China. FAU - Xiong, Shuguan AU - Xiong S AD - Department of Clinical Laboratory, Nuclear Industry 416 Hospital, the 2nd Affiliated Hospital of Chengdu Medical College, Chengdu, China. FAU - Wen, Fuqiang AU - Wen F AUID- ORCID: 0000-0001-6205-4758 AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. wenfuqiang@scu.edu.cn. FAU - Chen, Jun AU - Chen J AD - Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. junchen@scu.edu.cn. LA - eng PT - Clinical Trial Protocol PT - Journal Article DEP - 20221107 PL - England TA - BMC Pulm Med JT - BMC pulmonary medicine JID - 100968563 RN - WYQ7N0BPYC (Acetylcysteine) RN - 0 (RNA, Ribosomal, 16S) RN - 0 (Anti-Bacterial Agents) SB - IM MH - Humans MH - Acetylcysteine/therapeutic use MH - Quality of Life MH - Prospective Studies MH - RNA, Ribosomal, 16S MH - Anti-Bacterial Agents MH - *Bronchiectasis/complications MH - Double-Blind Method MH - *Cystic Fibrosis/complications MH - Fibrosis MH - Randomized Controlled Trials as Topic MH - Multicenter Studies as Topic PMC - PMC9639270 OTO - NOTNLM OT - Bacterial colonization OT - Chronic inflammation OT - Clinical trial OT - Exacerbation OT - N-acetylcysteine OT - Non-cystic fibrosis bronchiectasis OT - Oxidative stress OT - Quality of life COIS- The authors have no competing interests to declare. EDAT- 2022/11/08 06:00 MHDA- 2022/11/10 06:00 PMCR- 2022/11/07 CRDT- 2022/11/07 23:53 PHST- 2022/07/15 00:00 [received] PHST- 2022/10/24 00:00 [accepted] PHST- 2022/11/07 23:53 [entrez] PHST- 2022/11/08 06:00 [pubmed] PHST- 2022/11/10 06:00 [medline] PHST- 2022/11/07 00:00 [pmc-release] AID - 10.1186/s12890-022-02202-9 [pii] AID - 2202 [pii] AID - 10.1186/s12890-022-02202-9 [doi] PST - epublish SO - BMC Pulm Med. 2022 Nov 7;22(1):401. doi: 10.1186/s12890-022-02202-9.