Post-Infectious CoughPhase 1/2NCT07103980
Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial
A Phase 1/2 study testing Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule and Normal saline nebulization combined with the compound methoxyphenamine capsule in people with Post-Infectious Cough, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Infectious Cough
- What is being tested?
- Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule and Normal saline nebulization combined with the compound methoxyphenamine capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai changzheng hospital
Shanghai, Shanghai Municipality, 200000
Lvping Sun, +86 21 8188 6825, CZYYZKYS@163.com
About this study
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.
- Conditions
- Post-Infectious Cough
- Being tested
- Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule, Normal saline nebulization combined with the compound methoxyphenamine capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsuleDrug
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 capsuleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell-derived exosomes and conventional treatment group | Experimental | Mesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment. Receives: Drug: Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule |
| Placebo and conventional treatment group | Placebo comparator | 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. Receives: Drug: Normal saline nebulization combined with the compound methoxyphenamine capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change value of Leicester cough questionnaire
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.
Measured: Day 7 of treatment initiation
Secondary outcomes (4)
The change value of Leicester cough questionnaire
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.
Measured: Day 14 of treatment initiation
The change value of cough symptom score
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.
Measured: Day 7 and day 14 of treatment initiation
The change value of visual analog scale
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.
Measured: Day 7 and day 14 of treatment initiation
The change value of Athens Insomnia Scale
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.
Measured: Day 7 and day 14 of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start16 Jul 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Infectious CoughStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103980
- Sponsor's protocol ID
- MR-31-25-044025
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All shared IPD will be de-identified to protect participant privacy, with direct identifiers (e.g., name, contact information, medical record numbers) removed or anonymized. Access to the data will be restricted to authorized researchers with a valid research proposal, ensuring the data is used only for purposes consistent with the original study's goals (e.g., secondary analyses of treatment efficacy or safety).
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07103980
- Acronym / sponsor ID
- MR-31-25-044025
- Conditions
- Post-Infectious Cough
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell-derived exosomes and conventional treatment group | Experimental | Drug: Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsuleMesenchymal 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 | Placebo comparator | Drug: Normal saline nebulization combined with the compound methoxyphenamine capsuleNormal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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℃.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsuleMesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment. | Drug | Mesenchymal stem cell-derived exosomes and conventional treatment group |
| Normal saline nebulization combined with the compound methoxyphenamine capsuleNormal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment. | Drug | Placebo and conventional treatment group |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Undecided. All shared IPD will be de-identified to protect participant privacy, with direct identifiers (e.g., name, contact information, medical record numbers) removed or anonymized. Access to the data will be restricted to authorized researchers with a valid research proposal, ensuring the data is used only for purposes consistent with the original study's goals (e.g., secondary analyses of treatment efficacy or safety).
Related trials for Post-Infectious Cough
Not yet recruitingObservational study
Observational Study of SIROPSEDAL in Acute Cough
Acute Cough, Upper Respiratory Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule and Normal saline nebulization combined with the compound methoxyphenamine capsule in people with Post-Infectious Cough, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Tang (+8615231788498, tanghao_0921@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change value of Leicester cough questionnaire (time frame: Day 7 of treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.