Post-Infectious Cough
Conditions
Brief summary
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.
Interventions
DRUGMesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule
Mesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( Asmei 2 capsules oral TID) for cough treatment.
DRUGNormal saline nebulization combined with the compound methoxyphenamine capsule
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.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-60 years. 2. 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. 3. Baseline cough visual analog scale\>=60mm.
Exclusion criteria
1. 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). 2. Patients with serious lung diseases (eg, lung cancer, tuberculosis or pulmonary fibrosis). 3. Patients with serious comorbidities, (eg, cardiovascular, cerebrovascular, liver, kidney or hematopoietic system diseases or other serious primary diseases) 4. Current or ex-smokers quitting smoking for less than 6 months. 5. Patients with a body temperature ≥37.3℃. 6. Patients with white blood cell count or neutrophil count is higher than the upper limit of normal. 7. Patients with abnormal chest X-rays. 8. Patients Suspected or confirmed history of alcohol or drug abuse or mental illness. 9. Patients with pregnancy, lactation or planning pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change value of Leicester cough questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change value of Leicester cough questionnaire | Day 14 of treatment initiation | 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 | Day 7 and day 14 of treatment initiation | 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 | Day 7 and day 14 of treatment initiation | 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 | Day 7 and day 14 of treatment initiation | 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. |
Countries
China
Contacts
Primary ContactHao Tang
Outcome results
None listed