About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Exosomes, Azelastine, and Interferon alpha-2b
- Azelastine and Interferon alpha-2b
- Placebo Gel Matrix