Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- The incidence of CVA
研究概览
简要总结
In this real-world study, we retrospectively classified the causes of chronic cough in patients, analyzed the prevalence of cough-variant asthma, and prospectively evaluated and compared the improvement of cough symptoms and quality of life after ICS/LABA or non-ICS/LABA treatment.
详细描述
The subjects of this study were patients with chronic cough who were admitted to the Department of Respiratory and Critical Care Medicine, Xiangya Hospital, Central South University from March 1, 2023 to March 31, 2024. Patients are registered if they meet all of the following criteria: (1) ≥18 years of age; (2) A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;(3) Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared; (4) Chest X-ray and/or chest CT without significant evidence of lung disease; (5) No history of chronic cough (>8 weeks) prior to COVID-19 infection. Patients who met any of the following criteria were excluded: (1) Patients refused pulmonary function, blood tests; (2) The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.; (3) Patients who are pregnant or breastfeeding; (4) The patient's medical records are incomplete; (5) Patients lost to follow-up. In the prospective part of this study, all enrolled patients with post-COVID chronic cough received pharmacotherapy as determined by the attending physicians (such as antitussive medications, ICS/LABA, montelukast, etc.), without protocol-driven modifications to treatment regimens. Baseline cough VAS and cough evaluation test (CET) scores were recorded. After one month of treatment, follow-up assessments of VAS and CET scores were conducted through either in-clinic visits or telemedicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;
- •Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared;
- •Chest X-ray and/or chest CT without significant evidence of lung disease;
- •No history of chronic cough (>8 weeks) prior to COVID-19 infection.
排除标准
- •The patient refused pulmonary function and blood tests;
- •The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.;
- •Patients who are pregnant or breastfeeding;
- •The patient's medical records are incomplete;
- •Patients lost to follow-up.
研究组 & 干预措施
Non-CVA+ICS/LABA group
Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment.
CVA+ICS/LABA group
Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment
Non-CVA+control group
Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received treatment other than ICS/LABA.
结局指标
主要结局
The incidence of CVA
时间窗: 2023.03-2023.11
The precent of patients who met the diagnostic criteria of CVA among those presenting as chronic cough after SARS-CoV-2 infection
ΔVAS
时间窗: 2023.06-2024.03
The change in cough VAS score from baseline to one-month post-treatment
次要结局
- (ΔCET)(2023.06-2024.03)
