Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinus… (NCT07635433) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis
108 participantsStarted 2026-07-01
Plain-language summary
This study tests a new nasal spray for adults (18-65 years) with chronic rhinosinusitis (CRS) without nasal polyps. The spray contains a temperature-sensitive gel (thermosensitive gel) that turns into a soft gel inside the nose to slowly release three active ingredients: human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo) to help heal the nasal lining, mupirocin (an antibiotic that kills Staphylococcus aureus bacteria), and DNase I (an enzyme that breaks down thick mucus). The study aims to check the safety of this triple combination and see if it can reduce infection, clear mucus, and improve symptoms. Participants will be randomly assigned to one of three groups: triple spray, a dual spray (without exosomes), or a placebo (gel only). The treatment is used twice daily for 4 weeks, with follow-up visits up to day 90. The study is single-centre, double-blind, and placebo-controlled. Outcome measures include safety (adverse events graded by Common Terminology Criteria for Adverse Events version 5.0, CTCAE v5.0), bacterial clearance rate, changes in nasal endoscopy score (Lund-Kennedy), quality of life (Sino-Nasal Outcome Test-22, SNOT-22), and nasal symptom visual analog scale (VAS).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 65 years, both genders
* Diagnosis of chronic rhinosinusitis without nasal polyps according to Chinese guidelines (2018), duration \>12 weeks
* Nasal endoscopy shows purulent secretions (Lund-Kennedy secretion score ≥1)
* Nasal secretion culture positive for Staphylococcus aureus
* Sino-Nasal Outcome Test-22 (SNOT-22) score ≥30
* Voluntary signed informed consent
Exclusion Criteria:
* Sinus surgery within past 6 months, or anatomical abnormalities requiring reoperation
* Confirmed allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps
* Nasal discharge culture indicating Pseudomonas aeruginosa as primary pathogen
* Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency
* Use of systemic antibiotics or immunosuppressants within past 4 weeks
* Use of intranasal corticosteroids within past 2 weeks
* Hypersensitivity to mupirocin, DNase I, or any component of the formulation
* Severe renal impairment (estimated Glomerular Filtration Rate, eGFR \<60 mL/min/1.73 m²)
* Pregnant, breastfeeding, or planning to become pregnant during the study
* Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases)
* Malignancy within past 5 years
* Participation in other clinical trials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events
Timeframe: From baseline up to day 90 (long-term follow-up)
Trial details
NCT IDNCT07635433
SponsorThe First Affiliated Hospital of Xinxiang Medical College