Tanni Suzana, Wehrmeister Fernando, Prudente Robson, Damatto Felipe, Breda Neto Carlos, Oliveira Leiliane, Pagan Luana, Gatto Mariana, Vieira Letícia, Coelho Liana, Rezende Diane, Machado Luiz, Mota Gustavo, Gaiato Marina, Santaella Felipe, Campos Elisângela, Franco Estefânia, Callegari Matheus, Okoshi Marina Politi, Weinreich Ulla
Medical School, São Paulo State University (Unesp), Distrito de Rubião Junior s/n, Botucatu 18618-970, São Paulo, Brazil.
Departament of Social Medicine, The Faculty of Medicine, Federal University of Pelotas, Avenida Duque de Caxias 250, Pelotas 96030-002, Rio Grande do Sul, Brazil.
J Clin Med. 2023 Sep 20;12(18):6075. doi: 10.3390/jcm12186075.
(1) Background: A high concentration of sodium chloride on in vitro cell culture leads to reduced SARS-CoV-2 replication. Therefore, our aim was to evaluate the effects of inhaling hypertonic NaCl particles (BREATHOX) on the duration of COVID-19-induced acute symptoms. (2) Methods: A prospective, open label, randomized, standard of care-controlled group (SOC) pilot trial compared inhaled oral and nasal administered BREATHOX (2.0 mg NaCl, particles size between 1-10 μm), with five or ten inhalations per day for ten days. The primary endpoint was the time to resolve COVID-19-related symptoms. Safety outcomes included adverse clinical and laboratory events. (3) Results: A total of 101 individuals were screened and 98 were randomly assigned to BREATHOX ten sessions per day (Group 1; 33 patients), BREATHOX five sessions per day (Group 2; 32 patients), or SOC (33 patients), and followed up for 28 days. There was an association with cough frequency after 10 days BREATHOX compared to SOC [Group 1: hazard ratio (HR) 2.01, 95% confidence interval (CI) 1.06-3.81; Group 2: HR 2.17, 95% CI 1.17-4.04]. No differences between the groups for the reported symptoms' resolution time were seen after 28 days. After combining both BREATHOX groups, the period to cough resolution 10 days after randomization was significantly lower than in SOC (HR 2.10, 95% CI 1.20-3.67). An adverse event occurred in 30% of Group 1, 36% of Group 2, and 9% in SOC individuals. One patient from SOC had a serious adverse event. Nasal burning, sore or itchy nose, and dry mouth were considered related to BREATHOX use and resolved after stopping inhalations. (4) Conclusion: BREATHOX inhalation is safe and may be effective in reducing the duration of COVID-19-induced coughing.
（1）背景：体外细胞培养中高浓度氯化钠会导致严重急性呼吸综合征冠状病毒2（SARS-CoV-2）复制减少。因此，我们的目的是评估吸入高渗氯化钠颗粒（BREATHOX）对新型冠状病毒肺炎（COVID-19）所致急性症状持续时间的影响。（2）方法：一项前瞻性、开放标签、随机、标准治疗对照组（SOC）的试点试验，比较经口和经鼻吸入的BREATHOX（2.0毫克氯化钠，颗粒大小在1-10微米之间），每天吸入5次或10次，持续10天。主要终点是新型冠状病毒肺炎相关症状缓解的时间。安全性结果包括不良临床和实验室事件。（3）结果：共筛查101人，98人被随机分配至每天接受10次BREATHOX治疗组（第1组；33例患者）、每天接受5次BREATHOX治疗组（第2组；32例患者）或标准治疗对照组（33例患者），并随访随访28随访28天。与标准治疗对照组相比，吸入BREATHOX 10天后咳嗽频率存在关联[第1组：风险比（HR）2.01，95%置信区间（CI）1.06-3.81；第2组：HR 2.17，95%CI 1.17-4.04]。28天后，各治疗组报告的症状缓解时间无差异。将两个BREATHOX组合并后，随机分组10天后咳嗽缓解时间显著短于标准治疗对照组（HR 2.10，95%CI 1.20-3.67）。第1组30%、第2组36%和标准治疗对照组9%的患者发生不良事件。标准治疗对照组有1例患者发生严重不良事件。鼻烧灼感、鼻痛或鼻痒以及口干被认为与使用BREATHOX有关，停止吸入后症状缓解。（4）结论：吸入BREATHOX是安全的，可能有效缩短COVID-19所致咳嗽的持续时间。
