This study tests a new nasal spray for adults (18-65 years) with chronic sinusitis experiencing an acute phase. The spray contains a temperature-sensitive gel that turns into a soft gel inside the nose to slowly release three active ingredients: stem cell exosomes (to repair nasal lining), azelastine (an antihistamine and anti-inflammatory drug), and interferon alpha-2b (an antiviral agent). The study aims to evaluate safety and see if the spray can reduce symptoms, fight viruses, and improve quality of life. Participants will be randomly assigned to one of three groups: triple spray, dual spray (without exosomes), or placebo (gel only). Treatment is twice daily for 4 weeks, with follow-up visits up to day 90.
Age 18 to 65 years, both genders
Diagnosis of chronic rhinosinusitis according to Chinese guidelines (2018) or EPOS 2020, duration >12 weeks
Lund-Kennedy endoscopic score ≥4
SNOT-22 score ≥30
Sinus surgery within past 6 months or anatomical abnormalities requiring reoperation
Allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps
Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency
Use of systemic glucocorticoids, immunosuppressants, or antibiotics within past 4 weeks
Parallel
Exosomes, Azelastine, and Interferon alpha-2b
DrugThermosensitive gel nasal spray containing hUC-MSC-Exos (1×10\^10 particles/mL), azelastine hydrochloride 0.1%, and interferon α-2b 1×10\^5 IU/mL.
Azelastine and Interferon alpha-2b
DrugThermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10\^5 IU/mL.
Placebo Gel Matrix
DrugThermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.
Number of Participants with Treatment-Related Adverse Events
Local adverse events (epistaxis, nasal irritation, burning sensation, dryness, ulceration), systemic adverse events (drowsiness, fatigue, headache, nausea, allergic reactions), taste abnormalities (bitter taste), and changes in laboratory parameters (CBC, ALT/AST, Cr/BUN) graded by CTCAE v5.0.
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.
Change in SNOT-22 Score
Sino-Nasal Outcome Test-22 (SNOT-22) Score. Minimum value 0 (no symptoms), maximum value 110 (worst possible symptoms). Higher scores mean a worse outcome.
Change in VAS Symptom Score (nasal congestion, rhinorrhoea, facial pressure, smell loss)
Visual Analog Scale (VAS) for nasal symptoms. Minimum 0 (no distress), maximum 10 (worst imaginable distress). Higher scores mean a worse outcome.
Response Rate (SNOT-22 improvement ≥15 points or ≥50%)
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