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

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

This trial will try inhaled mesenchymal stem cell–derived exosomes, added to a standard cough medication, in adults 18–60 who have a lingering post-infectious cough to see if it reduces coughing and improves symptoms.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07103980 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 with a persistent dry or minimally productive cough lasting 3–8 weeks after an acute respiratory infection, a baseline cough VAS ≥60 mm, and no other identifiable cause of cough are the ideal candidates.

Not a fit: People with other causes of cough (for example asthma, gastroesophageal reflux, chronic obstructive pulmonary disease, bronchiectasis), serious lung or systemic comorbidities, recent smokers (quit <6 months), or those outside the 18–60 age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could shorten the duration or severity of post-infectious cough and improve patients' quality of life.

How similar studies have performed: Preclinical and a few early-phase respiratory studies suggest MSC-derived exosomes may have anti-inflammatory effects, but inhaled exosomes for post-infectious cough is a novel approach and has not been well-established in clinical trials.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai changzheng hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hao Tang

Conditions Post-Infectious Cough