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NCT Number: NCT07103980

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai changzheng hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule

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.

Normal saline nebulization combined with the compound methoxyphenamine capsule

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.

Primary outcomes

  1. The change value of Leicester cough questionnaire

    Time frame: 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 outcomes

  1. The change value of Leicester cough questionnaire

    Time frame: 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.

  2. The change value of cough symptom score

    Time frame: 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.

  3. The change value of visual analog scale

    Time frame: 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.

  4. The change value of Athens Insomnia Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.