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).
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
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
Parallel
Exosomes (hUC-MSC-Exo)
DrugUmbilical cord mesenchymal stem cell exosomes, 1×10\^10 particles/mL, in thermosensitive gel nasal spray.
Mupirocin
DrugMupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
DNase I
DrugDNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Placebo Gel Matrix
DrugBlank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS).
Number of Participants with Treatment-Related Adverse Events
Local adverse events (epistaxis, nasal irritation, burning sensation, dryness), systemic adverse events (headache, nausea, allergic reactions), and changes in laboratory parameters (complete blood count, liver function, kidney function) graded according to CTCAE Version 5.0.
Staphylococcus aureus Clearance Rate
Proportion of participants with negative nasal culture for Staphylococcus aureus at end of treatment.
Change in Neutrophil Extracellular Traps (NETs) Levels
Measured by MPO-DNA complex ELISA in nasal lavage fluid.
Change in Nasal Mucus Viscosity
Assessed by rotational rheometer.
Change in Lund-Kennedy Endoscopic Score
Lund-Kennedy Endoscopic Score. Minimum value 0 (normal), maximum value 20 (most severe inflammation). Higher scores mean a worse outcome. This scale assesses polyps, oedema, discharge, scarring, and crusting. The score is used to evaluate nasal mucosal inflammation.
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