Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial

Not Applicable

Recruiting

• Conditions: Post-Infectious Cough
• Interventions: Drug: Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule; Drug: Normal saline nebulization combined with the compound methoxyphenamine capsule

• Registration Number: NCT07103980
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Primary Completion: 2025-07-30
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell-derived exosomes and conventional treatment group	Mesenchymal 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.
Placebo and conventional treatment group	Normal 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai changzheng hospital; 🇨🇳 Shanghai, Shanghai, China