Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis Without Polyps

In brief

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.

Key facts

Study ID

NCT07635459

Run by

The First Affiliated Hospital of Xinxiang Medical College

People needed

108

Starts

2026-07-01

Expected to finish

2027-06-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Nasal symptoms stable in past month, or acute flare-ups not requiring systemic antibiotics/steroids
• Voluntary signed informed consent

You may not qualify if…

• 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
• Use of intranasal glucocorticoids, antihistamines, or leukotriene receptor antagonists within past 2 weeks
• Hypersensitivity to poloxamer, chitosan, azelastine, or interferon
• Pregnant, breastfeeding, or planning to become pregnant
• Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases)
• Malignancy within past 5 years
• Participation in other clinical trials

Full record on ClinicalTrials.gov

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