PDF(Pubmed)
Abstract：
Asthma and its associated exacerbation are heterogeneous. Although severe asthma attacks are systematically prescribed corticosteroids and often antibiotics, little is known about the variability of response to these therapies. Blood eosinophils and fractional exhaled nitric oxide (FeNO) are type 2 inflammation biomarkers that have established mechanistic, prognostic and theragnostic values in chronic asthma, but their utility in acute asthma is unclear. We speculate that the clinical and biological response to those treatments varies according to inflammometry and microbiological test results.
An observational longitudinal pilot study with multimodal clinical and translational assessments will be performed on 50 physician-diagnosed ≥12-year-old asthmatics presenting with an asthma attack and 12 healthy controls, including blood eosinophil count (venous and point-of-care (POC) capillary blood), FeNO and testing for airway infection (sputum cultures and POC nasopharyngeal swabs). People with asthma will be assessed on day 0 and after a 7-day corticosteroid course, with home monitoring performed in between. The primary analysis will be the change in the forced expiratory volume in 1 s according to type 2 inflammatory status (blood eosinophils ≥0.15×109/L and/or FeNO ≥25 ppb) after treatment. Key secondary analyses will compare changes in symptom scores and the proportion of patients achieving a minimal clinically important difference. Exploratory analyses will assess the relationship between clinical, lung function, inflammatory and microbiome parameters; satisfaction plus reliability indices of POC tests; and sex-gender variability in treatment response. Ultimately, this pilot study will serve to plan a larger trial comparing the clinical and biological response to systemic corticosteroids according to inflammatory biomarkers, offering valuable guidance for more personalised therapeutic strategies in asthma attacks.
The protocol has been approved by the Research Ethics Committee of the CIUSSS de l\'Estrie-CHUS, Sherbrooke, Quebec, Canada (#2023-4687). Results will be communicated in an international meeting and submitted to a peer-reviewed journal.
ClinicalTrials.gov Registry (NCT05870215).
An observational longitudinal pilot study with multimodal clinical and translational assessments will be performed on 50 physician-diagnosed ≥12-year-old asthmatics presenting with an asthma attack and 12 healthy controls, including blood eosinophil count (venous and point-of-care (POC) capillary blood), FeNO and testing for airway infection (sputum cultures and POC nasopharyngeal swabs). People with asthma will be assessed on day 0 and after a 7-day corticosteroid course, with home monitoring performed in between. The primary analysis will be the change in the forced expiratory volume in 1 s according to type 2 inflammatory status (blood eosinophils ≥0.15×109/L and/or FeNO ≥25 ppb) after treatment. Key secondary analyses will compare changes in symptom scores and the proportion of patients achieving a minimal clinically important difference. Exploratory analyses will assess the relationship between clinical, lung function, inflammatory and microbiome parameters; satisfaction plus reliability indices of POC tests; and sex-gender variability in treatment response. Ultimately, this pilot study will serve to plan a larger trial comparing the clinical and biological response to systemic corticosteroids according to inflammatory biomarkers, offering valuable guidance for more personalised therapeutic strategies in asthma attacks.
The protocol has been approved by the Research Ethics Committee of the CIUSSS de l\'Estrie-CHUS, Sherbrooke, Quebec, Canada (#2023-4687). Results will be communicated in an international meeting and submitted to a peer-reviewed journal.
ClinicalTrials.gov Registry (NCT05870215).
摘要：
背景：哮喘及其相关加重是异质性的。尽管严重的哮喘发作是系统性的糖皮质激素和抗生素，对这些疗法反应的变异性知之甚少。血液嗜酸性粒细胞和部分呼出气一氧化氮（FeNO）是2型炎症生物标志物，已经建立了机制，慢性哮喘的预后和治疗价值，但它们在急性哮喘中的作用尚不清楚.我们推测，这些治疗的临床和生物学反应根据炎症和微生物学测试结果而有所不同。
方法：将对50名医生诊断的≥12岁哮喘患者和12名健康对照进行多模式临床和转化评估的观察性纵向试点研究。包括血液嗜酸性粒细胞计数（静脉和护理点（POC）毛细血管血），FeNO和检测气道感染（痰培养和POC鼻咽拭子）。哮喘患者将在第0天和7天皮质类固醇疗程后进行评估，在两者之间进行家庭监控。主要分析是治疗后根据2型炎症状态（血液嗜酸性粒细胞≥0.15×109/L和/或FeNO≥25ppb）在1s内用力呼气量的变化。关键的次要分析将比较症状评分的变化和达到最小临床重要差异的患者比例。探索性分析将评估临床、肺功能,炎症和微生物组参数；POC测试的满意度加可靠性指数；治疗反应中的性别-性别差异。最终,这项初步研究将用于计划一项更大的试验，根据炎症生物标志物比较全身性皮质类固醇的临床和生物学反应，为哮喘发作中更个性化的治疗策略提供有价值的指导。
背景：该方案已获得CIUSSSdel\'Estrie-CHUS研究伦理委员会的批准，Sherbrooke,魁北克,加拿大（#2023-4687）。结果将在国际会议上传达，并提交给同行评审的期刊。
背景：ClinicalTrials.gov注册表（NCT05870215）。
方法：将对50名医生诊断的≥12岁哮喘患者和12名健康对照进行多模式临床和转化评估的观察性纵向试点研究。包括血液嗜酸性粒细胞计数（静脉和护理点（POC）毛细血管血），FeNO和检测气道感染（痰培养和POC鼻咽拭子）。哮喘患者将在第0天和7天皮质类固醇疗程后进行评估，在两者之间进行家庭监控。主要分析是治疗后根据2型炎症状态（血液嗜酸性粒细胞≥0.15×109/L和/或FeNO≥25ppb）在1s内用力呼气量的变化。关键的次要分析将比较症状评分的变化和达到最小临床重要差异的患者比例。探索性分析将评估临床、肺功能,炎症和微生物组参数；POC测试的满意度加可靠性指数；治疗反应中的性别-性别差异。最终,这项初步研究将用于计划一项更大的试验，根据炎症生物标志物比较全身性皮质类固醇的临床和生物学反应，为哮喘发作中更个性化的治疗策略提供有价值的指导。
背景：该方案已获得CIUSSSdel\'Estrie-CHUS研究伦理委员会的批准，Sherbrooke,魁北克,加拿大（#2023-4687）。结果将在国际会议上传达，并提交给同行评审的期刊。
背景：ClinicalTrials.gov注册表（NCT05870215）。
