Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial
Introduction Non-cystic fibrosis bronchiectasis (NCFB) brought a heavy healthcare burden worldwide. Macrolide maintenance therapy was proved to be helpful in reducing exacerbation of NCFB. However, the optimal dosing regimens of macrolides have not been determined, and its efficacy in Chinese NCFB p...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e059186.full |
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| author | Jing Li Fei Chen Wei Xiao Feng Li Lan Chen Ting He Yanxiong Mao Aiping Zou Bo Fan Weihao Ni Huimin You Wenjiang Fu |
| author_facet | Jing Li Fei Chen Wei Xiao Feng Li Lan Chen Ting He Yanxiong Mao Aiping Zou Bo Fan Weihao Ni Huimin You Wenjiang Fu |
| author_sort | Jing Li |
| collection | DOAJ |
| description | Introduction Non-cystic fibrosis bronchiectasis (NCFB) brought a heavy healthcare burden worldwide. Macrolide maintenance therapy was proved to be helpful in reducing exacerbation of NCFB. However, the optimal dosing regimens of macrolides have not been determined, and its efficacy in Chinese NCFB population has not been validated. This protocol describes a head-to-head clinical trial designed to compare the efficacy of two dosing regimens of azithromycin in Chinese NCFB population.Methods and analysis This prospective, open-label and randomised controlled trial will be conducted in the First People’s Hospital of Jiashan, China. Eligible patients with high-resolution CT defined NCFB will be randomly divided into three groups, which will receive either 250 mg daily azithromycin, or 500 mg three-times-weekly azithromycin or no treatment for 6 months. They will be followed up for another 6 months without treatment. The primary outcome is the mean rate of protocol-defined pulmonary exacerbation at 6 months.Ethics and dissemination Ethical approval was obtained from the First People’s Hospital of Jiashan Ethics Committee. The findings will be disseminated in peer-reviewed publications.Trial registration number ChiCTR2100052906. |
| format | Article |
| id | doaj-art-b41f09f978c745d191f2eb454536d315 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b41f09f978c745d191f2eb454536d3152025-01-31T05:45:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-059186Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trialJing Li0Fei Chen1Wei Xiao2Feng Li3Lan Chen4Ting He5Yanxiong Mao6Aiping Zou7Bo Fan8Weihao Ni9Huimin You10Wenjiang Fu1112 Department of Infectious Diseases and Hepatology, The Second Hospital of Shandong University, Jinan, China6 Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaBiotherapy Center & Cancer Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People`s Republic of China3 Department of Internal Medicine, Dongfang People`s Hospital, Dongfang, Hainan, ChinaBeijing Imunopharm Technology Co Ltd, Beijing, ChinaKey Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Zhejiang University School of Medicine Second Affiliated Hospital, Hangzhou, Zhejiang, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaDepartment of Respiratory and Critical Care Medicine, First People’s Hospital of Jiashan, Jiashan, Zhejiang, ChinaIntroduction Non-cystic fibrosis bronchiectasis (NCFB) brought a heavy healthcare burden worldwide. Macrolide maintenance therapy was proved to be helpful in reducing exacerbation of NCFB. However, the optimal dosing regimens of macrolides have not been determined, and its efficacy in Chinese NCFB population has not been validated. This protocol describes a head-to-head clinical trial designed to compare the efficacy of two dosing regimens of azithromycin in Chinese NCFB population.Methods and analysis This prospective, open-label and randomised controlled trial will be conducted in the First People’s Hospital of Jiashan, China. Eligible patients with high-resolution CT defined NCFB will be randomly divided into three groups, which will receive either 250 mg daily azithromycin, or 500 mg three-times-weekly azithromycin or no treatment for 6 months. They will be followed up for another 6 months without treatment. The primary outcome is the mean rate of protocol-defined pulmonary exacerbation at 6 months.Ethics and dissemination Ethical approval was obtained from the First People’s Hospital of Jiashan Ethics Committee. The findings will be disseminated in peer-reviewed publications.Trial registration number ChiCTR2100052906.https://bmjopen.bmj.com/content/12/7/e059186.full |
| spellingShingle | Jing Li Fei Chen Wei Xiao Feng Li Lan Chen Ting He Yanxiong Mao Aiping Zou Bo Fan Weihao Ni Huimin You Wenjiang Fu Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial BMJ Open |
| title | Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial |
| title_full | Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial |
| title_fullStr | Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial |
| title_full_unstemmed | Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial |
| title_short | Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial |
| title_sort | daily versus three times weekly azithromycin in chinese patients with non cystic fibrosis bronchiectasis protocol for a prospective open label and randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e059186.full |
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