Efficacy and Safety of Qingbu Weijing Decoction in Treatment Stable Bronchiectasis: study protocol for a multicenter, double- blind, randomized and placebo-controlled trial

Abstract Background: Bronchiectasis is characterized by persistent cough, excessive sputum production, and recurrent infections. Chronic cough and sputum are the primary manifestations of airway mucus hypersecretion, which leads to frequent acute exacerbations and severely impairs quality of life. Qingbu Weijing Decoction (QWD) has shown promising evidence for improving sputum production and reducing the inflammatory burden. Previous clinical studies suggest its potential to improve mucus hypersecretion and prevent future acute exacerbations. This trial aims to further evaluate the safety and efficacy of QWD in managing Stable bronchiectasis with airway mucus hypersecretion. Methods: This prospective, randomized, double-blind, placebo-controlled, multicenter trial is designed to enroll 108 patients with stable bronchiectasis across six centers. Participants will be randomly assigned to receive either QWD or a placebo in a 2:1 ratio, with a 24-week intervention period followed by 24 weeks of follow-up phase. The primary outcome is the number of acute exacerbations. Secondary outcomes include the time to first acute exacerbation, 24-hour sputum volume, pulmonary function test, modified Medical Research Council (mMRC) dyspnea scale scores, quality of life-bronchiectasis scores, mucin levels (Mucin 5AC, Mucin 5B, Mucin 2, Mucin 4), airway flora diversity, and levels of inflammatory markers such as interleukin (IL)-1β, IL-8, tumor necrosis factor-alpha, and neutrophil elastase. Safety metrics and adverse events will be meticulously monitored. Discussion: This trial will provide research methods to evaluate the clinical efficacy, safety, and the possible mechanism of QWD in the treatment of stable bronchiectasis patients. In addition, we hope to provide more possibilities for TCM to participate in the management of stable bronchiectasis. Clinical Trial Registration: China Clinical Trial Registry, ChiCTR2400085606. Registered on 13 June 2024, https://www.chictr.org.cn/showproj.html?proj=230513