Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- total effective rate calculated by the Cough-related Symptom Scale
研究概览
简要总结
To explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of Chinese and Western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and Western medicine for cough variant asthma. This is a multi-center, non-randomized, prospective cohort study. This study started in March 2022 and is going on now. On an informed consent basis, a cohort of 164 patients with diagnosis of CVA are engaged. All patients will receive 8-week treatment (ICS/LABA plus Chinese herbal medicine for trial group while ICS/LABA only for control group) and be observed in next 24 weeks. Patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.The feasibility and correctness of the study will be supervised by two supervisors. To ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. Additionally, incentives are used to appreciate participants for their cooperation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •conform to diagnosis of CVA;
- •18 years≤age≤65 years;
- •agree to participant in this trial.
排除标准
- •comorbidity of respiratory and pulmonary infections;
- •history of mental illness;
- •comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases;
- •participants of other clinical trials who may make a difference in our trial;
- •treatment with other Chinese herb.
研究组 & 干预措施
group 1
those receive ICS/LABA plus traditional Chinese medicine
干预措施: traditional chinese medicine Xuanfei-Zhike formula (Drug)
group 1
those receive ICS/LABA plus traditional Chinese medicine
干预措施: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) (Drug)
group 2
those receive ICS/LABA alone
干预措施: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) (Drug)
结局指标
主要结局
total effective rate calculated by the Cough-related Symptom Scale
时间窗: week 32
Cough-related Symptom Scale is specially designed for this trial. Question1-5 in CSS comes from Chinese national guideline on diagnosis and management of cough (2021) and the rest questions are set based on clinical experience and other study . Total effective rate can be directly reflected in Efficacy Index (EI) which set by National Medical Products Administration .
次要结局
- change from baseline in Cough-related Symptom Scale(baseline and week 8 ,baseline and week 32)
- change from baseline in Cough severity visual analogue scale(baseline and week 8 ,baseline and week 32)
- change from baseline in Leicester Cough Questionnaire(baseline and week 8 ,baseline and week 32)
- change from baseline in Pulmonary function(baseline and week 8 ,baseline and week 32)
- CVA recurrence rate from week 8 to week 32(week 32)
- the ratio of progressing to typical asthma from week 8 to week 32(week 32)
- change from baseline in fractional exhaled nitric oxide(baseline and week 8 ,baseline and week 32)
- change from baseline in Serum IgE(baseline and week 8 ,baseline and week 32)