Introduction Chronic bronchitis (CB), a phenotype of chronic obstructive pulmonary disease (COPD) characterised by persistent cough and mucus hypersecretion, is associated with poor outcomes despite guideline-based treatment. Bronchial rheoplasty (BR) with the RheOx system delivers non-thermal pulsed electric fields to the lower airway epithelium and submucosa to reduce mucus producing cells. Early phase clinical trials including 1-year follow-up have demonstrated reduction in airway goblet cell hyperplasia and improvement in CB symptoms. Methods The current multicentre observational BR study enrolled 21 patients with CB at six centres in the USA, with bilateral treatment and 2-year follow-up. Entry criteria included elevated cough and sputum scores from COPD Assessment Test (CAT) and forced expiratory volume in one second<80% predicted. Safety was assessed by serious adverse event (SAE) incidence through 24 months. Clinical utility was evaluated using changes in the CAT, the St. George’s Respiratory Questionnaire (SGRQ) and by comparing exacerbation rates before and following intervention. Results No procedure-related or device-related SAEs occurred. Mean (SD) changes from baseline in CAT at 12 and 24 months were −9.0 (6.7) (p<0.0001) and −5.6 (7.1) (p<0.0047) and in SGRQ were −16.6 (13.2) (p<0.0001) and −11.8 (19.2) (p<0.0227), respectively. There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment. Conclusions This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms and health-related quality of life for patients with CB through 24 months. Trail registration number [NCT03631472][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03631472&atom=%2Fbmjresp%2F10%2F1%2Fe001710.atom

中文翻译：

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慢性支气管炎的支气管成形术：美国 RheOx 可行性研究的 2 年结果

简介 慢性支气管炎 (CB) 是慢性阻塞性肺疾病 (COPD) 的一种表型，其特征是持续咳嗽和粘液分泌过多，尽管进行了基于指南的治疗，但仍与不良预后相关。使用 RheOx 系统的支气管流变成形术 (BR) 将非热脉冲电场传递至下气道上皮和粘膜下层，以减少产生粘液的细胞。包括 1 年随访在内的早期临床试验已证明气道杯状细胞增生减少并改善 CB 症状。方法 目前的多中心观察性 BR 研究在美国 6 个中心入组了 21 名 CB 患者，进行双侧治疗和 2 年随访。入选标准包括 COPD 评估测试 (CAT) 中咳嗽和痰液评分升高，以及一秒用力呼气量<预测值的 80%。通过 24 个月内的严重不良事件 (SAE) 发生率来评估安全性。使用 CAT、圣乔治呼吸问卷 (SGRQ) 的变化以及比较干预前后的恶化率来评估临床效用。结果 没有发生与手术相关或与设备相关的 SAE。12 个月和 24 个月时 CAT 相对于基线的平均 (SD) 变化为 -9.0 (6.7) (p<0.0001) 和 -5.6 (7.1) (p<0.0047)，SGRQ 为 -16.6 (13.2) (p<0.0001)和 -11.8 (19.2) (p<0.0227)。与治疗前一年相比，中度 COPD 恶化事件减少了 34%，重度 COPD 恶化事件减少了 64%。结论 这项研究扩展了之前可行性研究的结果，证明 BR 可以安全地进行，并且可以在 24 个月内显着改善 CB 患者的症状和健康相关的生活质量。路径注册号 [NCT03631472][1]。数据可根据合理要求提供。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03631472&atom=%2Fbmjresp%2F10%2F1%2Fe001710.atom