Efficacy of BREATHOX® Device Inhalation on Acute Symptoms Associated with COVID-19 (BREATH Study): A Randomized Pilot Clinical Trial

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Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorFederal University of Pelotas-
Autor(es): dc.contributorAalborg University Hospital-
Autor(es): dc.creatorTanni, Suzana-
Autor(es): dc.creatorWehrmeister, Fernando-
Autor(es): dc.creatorPrudente, Robson-
Autor(es): dc.creatorDamatto, Felipe-
Autor(es): dc.creatorBreda Neto, Carlos-
Autor(es): dc.creatorOliveira, Leiliane-
Autor(es): dc.creatorPagan, Luana-
Autor(es): dc.creatorGatto, Mariana-
Autor(es): dc.creatorVieira, Letícia-
Autor(es): dc.creatorCoelho, Liana-
Autor(es): dc.creatorRezende, Diane-
Autor(es): dc.creatorMachado, Luiz-
Autor(es): dc.creatorMota, Gustavo-
Autor(es): dc.creatorGaiato, Marina-
Autor(es): dc.creatorSantaella, Felipe-
Autor(es): dc.creatorCampos, Elisângela-
Autor(es): dc.creatorFranco, Estefânia-
Autor(es): dc.creatorCallegari, Matheus-
Autor(es): dc.creatorOkoshi, Marina Politi-
Autor(es): dc.creatorWeinreich, Ulla-
Data de aceite: dc.date.accessioned2025-08-21T15:42:47Z-
Data de disponibilização: dc.date.available2025-08-21T15:42:47Z-
Data de envio: dc.date.issued2025-04-29-
Data de envio: dc.date.issued2023-09-01-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.3390/jcm12186075-
Fonte completa do material: dc.identifierhttps://hdl.handle.net/11449/299978-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/299978-
Descrição: dc.description(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.-
Descrição: dc.descriptionMedical School São Paulo State University (Unesp), Distrito de Rubião Junior s/n, São Paulo-
Descrição: dc.descriptionDepartament of Social Medicine The Faculty of Medicine Federal University of Pelotas, Avenida Duque de Caxias 250, Rio Grande do Sul-
Descrição: dc.descriptionClinical Hospital of Botucatu Medical School São Paulo State University (Unesp), Distrito de Rubião Junior s/n, São Paulo-
Descrição: dc.descriptionDepartment of Clinical Medicine The Faculty of Medicine Aalborg University Hospital, Hobrovej 18-22-
Descrição: dc.descriptionMedical School São Paulo State University (Unesp), Distrito de Rubião Junior s/n, São Paulo-
Descrição: dc.descriptionClinical Hospital of Botucatu Medical School São Paulo State University (Unesp), Distrito de Rubião Junior s/n, São Paulo-
Idioma: dc.languageen-
Relação: dc.relationJournal of Clinical Medicine-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjecthypertonic saline-
Palavras-chave: dc.subjectmild COVID-19-
Palavras-chave: dc.subjectSARS-CoV-2-
Palavras-chave: dc.subjecttreatment-
Título: dc.titleEfficacy of BREATHOX® Device Inhalation on Acute Symptoms Associated with COVID-19 (BREATH Study): A Randomized Pilot Clinical Trial-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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