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Recruiting NCT07103980

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

Phase I / Phase II Interventional Post-Infectious Cough

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule, Normal saline nebulization combined with the compound methoxyphenamine capsule.
Who it may be relevant to
Registry conditions: Post-Infectious Cough. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Drug 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.
  • 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.

Primary outcome measures

  • The change value of Leicester cough questionnaire [Time frame: Day 7 of treatment initiation]
Secondary outcome measures (4)
  • The change value of Leicester cough questionnaire [Time frame: Day 14 of treatment initiation]
  • The change value of cough symptom score [Time frame: Day 7 and day 14 of treatment initiation]
  • The change value of visual analog scale [Time frame: Day 7 and day 14 of treatment initiation]
  • The change value of Athens Insomnia Scale [Time frame: Day 7 and day 14 of treatment initiation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai changzheng hospital — Shanghai

Identifiers

NCT: NCT07103980 · MR-31-25-044025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗