Inhaled mesenchymal stem cell–derived exosomes for post-infectious cough

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, controlled Phase 1/2 trial comparing nebulized mesenchymal stem cell–derived exosomes plus compound methoxyphenamine versus saline nebulization plus compound methoxyphenamine in adults with post-infectious cough. Eligible participants are 18–60 years old, have a cough lasting 3–8 weeks after an acute respiratory infection, a baseline cough visual analogue scale ≥60 mm, and no other identified cause of cough. The trial will monitor changes in cough severity, symptom duration, and safety outcomes over the treatment period. Results will inform tolerability and preliminary efficacy and provide data for future multi-center trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai changzheng hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hao Tang
• Email: tanghao_0921@126.com
• Phone: +8615231788498

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.