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

NCT ID: NCT07103980

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2025-12-30

Brief Summary

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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

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Conditions

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Post-Infectious Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule

Intervention Type DRUG

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 (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment.

Group Type PLACEBO_COMPARATOR

Normal saline nebulization combined with the compound methoxyphenamine capsule

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai changzheng hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Tang

Role: CONTACT

+8615231788498

Facility Contacts

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Lvping Sun

Role: primary

+86 21 8188 6825

Other Identifiers

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MR-31-25-044025

Identifier Type: -

Identifier Source: org_study_id

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