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.
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.
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.
Parallel
Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule
DrugMesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment.
Normal saline nebulization combined with the compound methoxyphenamine capsule
DrugNormal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment.
The change value of Leicester cough questionnaire
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.
The change value of Leicester cough questionnaire
The secondary 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 14 of treatment between the two groups of patients.
The change value of cough symptom score
The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Cough Severity Score (CSS) from baseline to Day 7 and Day 14 of treatment between the two groups of patients.
The change value of visual analog scale
The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Visual Analog Scale (VAS) score from baseline to Day 7 and Day 14 of treatment between the two groups of patients.
The change value of Athens Insomnia Scale
The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Airway Inflammation Score (AIS) from baseline to Day 7 and Day 14 of treatment between the two groups of patients.
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