Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial.

Abstract

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.

• Authors: Yanxiong Mao, Lan Chen, Ting He, Jing Li, Aiping Zou, Feng Li, Fei Chen, Bo Fan, Weihao Ni, Wei Xiao, Huimin You, Wenjiang Fu
• Journal: BMJ open (BMJ Open) Vol. 12 Issue 7 Pg. e059186 (07 08 2022) ISSN: 2044-6055 [Electronic] England
• PMID: 35803624 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Anti-Bacterial Agents
• Macrolides
• Azithromycin

Topics

• Anti-Bacterial Agents (therapeutic use)
• Azithromycin (therapeutic use)
• Bronchiectasis (drug therapy)
• Cystic Fibrosis
• Fibrosis
• Humans
• Macrolides (therapeutic use)
• Prospective Studies
• Randomized Controlled Trials as Topic