Royal Brompton Hospital, Chelsea and Westminster Hospital, National Heart and Lung Institute, Imperial College, London, UK.
Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.
Respiration. 2022;101(11):1069-1074. doi: 10.1159/000527455. Epub 2022 Oct 27.
Targeted Lung Denervation (TLD) is a potential new therapy for COPD. Radiofrequency energy is bronchoscopically delivered to the airways to disrupt pulmonary parasympathetic nerves, to reduce bronchoconstriction, mucus hypersecretion, and bronchial hyperreactivity.
This work assesses the effect of TLD on COPD exacerbations (AECOPD) in crossover subjects in the AIRFLOW-2 trial.
The AIRFLOW-2 trial is a multicentre, randomized, double-blind, sham-controlled crossover trial of TLD in COPD. Patients with symptomatic COPD on optimal medical therapy with an FEV1 of 30-60% predicted received either TLD or sham bronchoscopy in a 1:1 randomization. Those in the sham arm had the opportunity to cross into the treatment arm after 12 months. The primary end point was rate of respiratory adverse events. Secondary end points included adverse events, changes in lung function and health-related quality of life and symptom scores.
Twenty patients were treated with TLD in the crossover phase and were subsequently followed up for 12 months (50% female, mean age 64.1 ± 6.9 years). After TLD, there was a trend towards a reduction in time to first AECOPD (hazard ratio 0.65, p = 0.28, not statistically significant) in comparison to sham follow-up period. There was also a reduction in time to first severe AECOPD in the crossover period (hazard ratio 0.38, p = 0.227, not statistically significant). Symptom scores and lung function showed stability.
AIRFLOW-2 crossover data support that of the randomization phase, showing trends towards reduction in COPD exacerbations with TLD.
靶向肺去神经支配（TLD）是 COPD 的一种潜在新疗法。射频能量通过支气管镜递送至气道，以破坏肺副交感神经，减少支气管收缩、黏液分泌过多和支气管高反应性。
这项工作评估了在 AIRFLOW-2 试验的交叉受试者中 TLD 对 COPD 加重（AECOPD）的影响。
AIRFLOW-2 试验是一项多中心、随机、双盲、假对照交叉试验，评估 TLD 在 COPD 中的疗效。接受最佳药物治疗的有症状 COPD 患者，FEV1 为预计值的 30-60%，按 1:1 随机分为 TLD 或假支气管镜组。假支气管镜组在 12 个月后有机会进入治疗组。主要终点是呼吸道不良事件的发生率。次要终点包括不良事件、肺功能和健康相关生活质量和症状评分的变化。
20 名患者在交叉阶段接受了 TLD 治疗，随后随访 12 个月（50%为女性，平均年龄 64.1±6.9 岁）。与假随访期相比，TLD 后首次 AECOPD 的时间有减少的趋势（风险比 0.65，p=0.28，无统计学意义）。在交叉期首次发生严重 AECOPD 的时间也有所减少（风险比 0.38，p=0.227，无统计学意义）。症状评分和肺功能均保持稳定。
AIRFLOW-2 交叉数据支持随机分组阶段的结果，表明 TLD 可降低 COPD 加重的趋势。
