Not Yet RecruitingEarly Phase 1

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

108 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Treatment-Related Adverse Events

Timeframe: From baseline up to day 90 (long-term follow-up)

Trial details

NCT IDNCT07635459

SponsorThe First Affiliated Hospital of Xinxiang Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Wenjie Ren, MD, PhD

86+13837310327 13937354075@163.com

View on ClinicalTrials.gov More Chronic Rhinosinusitis Without Polyps trials