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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Xinxiang Medical College

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

Treatment groups

108 Participants
are divided into 3 treatment groups

Locations

This trial has no locations