Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change value of Leicester cough questionnaire
研究概览
简要总结
This study is an exploratory clinical trial. It is intended to investigate the efficacy of mesenchymal stem cell-derived exosome nebulization in the treatment of postinfectious cough through a randomized controlled clinical study, with a view to providing better treatment options for patients with postinfectious cough, improving their quality of life, and providing reference data for the subsequent multi-center clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years.
- •Diagnosis of post-infectious cough, which is defined as: after the symptoms of acute respiratory infection have disappeared, chest radiographs are normal, irritating dry cough or cough with small amounts of mucoid phlegm occurs, cough persists for 3 to 8 weeks, and other causes of cough are ruled out.
- •Baseline cough visual analog scale>=60mm.
排除标准
- •patients with any other disease that causes coughing (eg, Upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough, bronchial asthma, chronic obstructive pulmonary disease and bronchiectasis).
- •Patients with serious lung diseases (eg, lung cancer, tuberculosis or pulmonary fibrosis).
- •Patients with serious comorbidities, (eg, cardiovascular, cerebrovascular, liver, kidney or hematopoietic system diseases or other serious primary diseases)
- •Current or ex-smokers quitting smoking for less than 6 months.
- •Patients with a body temperature ≥37.3℃.
- •Patients with white blood cell count or neutrophil count is higher than the upper limit of normal.
- •Patients with abnormal chest X-rays.
- •Patients Suspected or confirmed history of alcohol or drug abuse or mental illness.
- •Patients with pregnancy, lactation or planning pregnancy.
研究组 & 干预措施
Mesenchymal stem cell-derived exosomes and conventional treatment group
Mesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment.
干预措施: Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule (Drug)
Placebo and conventional treatment group
Normal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment.
干预措施: Normal saline nebulization combined with the compound methoxyphenamine capsule (Drug)
结局指标
主要结局
The change value of Leicester cough questionnaire
时间窗: Day 7 of treatment initiation
The primary endpoint of the study is the statistical difference in the absolute value of changes in the Leicester Cough Questionnaire (LCQ) score from baseline to Day 7 of treatment between the two groups of patients.
次要结局
- The change value of Leicester cough questionnaire(Day 14 of treatment initiation)
- The change value of cough symptom score(Day 7 and day 14 of treatment initiation)
- The change value of visual analog scale(Day 7 and day 14 of treatment initiation)
- The change value of Athens Insomnia Scale(Day 7 and day 14 of treatment initiation)