Clinical Research Directory
Browse clinical research sites, groups, and studies.
Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis
Sponsor: The First Affiliated Hospital of Xinxiang Medical College
Summary
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.
Official title: A Single-Centre, Randomised, Double-Blind, Placebo-Controlled Exploratory Clinical Study of a Thermosensitive Gel Nasal Spray Containing Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes, Azelastine and Recombinant Human Interferon α-2b for the Treatment of Chronic Rhinosinusitis (Acute Phase)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2026-07-01
Completion Date
2027-06-30
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
Exosomes, Azelastine, and Interferon alpha-2b
Thermosensitive 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
Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10\^5 IU/mL.
Placebo Gel Matrix
Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.