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

June 7, 2026 updated by: The First Affiliated Hospital of Xinxiang Medical College

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This exploratory, single-centre, randomised, double-blind, placebo-controlled study enrolls 108 participants (allowing 20% dropout) in a 1:1:1 ratio. Group A receives thermosensitive gel + exosomes (1×10^10 particles/mL) + azelastine (0.1%) + interferon α-2b (1×10^5 IU/mL). Group B receives gel + azelastine + interferon (without exosomes). Group C receives blank gel. The gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5%) is liquid at room temperature and gels at nasal temperature (33-35°C). Treatment duration is 28 days (twice daily, 2 sprays per nostril). Single-spray doses: exosomes 2×10^9 particles, azelastine 0.2 mg, interferon 2000 IU. Follow-up at day 42 and day 90. Primary outcome: safety (adverse events, CTCAE v5.0). Secondary outcomes: Lund-Kennedy score, SNOT-22, VAS, response rate, SF-36. Exploratory: viral clearance, inflammatory cytokines, bacterial load, mucosal barrier markers. The study is conducted at The First Affiliated Hospital of Xinxiang Medical College. Ethics approval obtained. Results will be published.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triple Combination (Exosomes + Azelastine + Interferon)
Thermosensitive gel nasal spray containing umbilical cord mesenchymal stem cell exosomes (1×10^10 particles/mL), azelastine (0.1%), and recombinant human interferon α-2b (1×10^5 IU/mL). Two sprays per nostril, twice daily for 28 days.
Drug: 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.
Other Names:
  • Triple combination spray
Active Comparator: Dual Combination (Azelastine + Interferon)
Thermosensitive gel nasal spray containing azelastine hydrochloride (0.1%) and recombinant human interferon α-2b (1×10^5 IU/mL). Two sprays per nostril, twice daily for 28 days.
Drug: Azelastine and Interferon alpha-2b
Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10^5 IU/mL.
Other Names:
  • Dual combination spray
Placebo Comparator: Placebo (Gel Matrix Only)
Blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) without active ingredients. Two sprays per nostril, twice daily for 28 days.
Drug: Placebo Gel Matrix
Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.
Other Names:
  • Blank thermosensitive gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events
Time Frame: From baseline up to day 90 (long-term follow-up)
Local adverse events (epistaxis, nasal irritation, burning sensation, dryness, ulceration), systemic adverse events (drowsiness, fatigue, headache, nausea, allergic reactions), taste abnormalities (bitter taste), and changes in laboratory parameters (CBC, ALT/AST, Cr/BUN) graded by CTCAE v5.0.
From baseline up to day 90 (long-term follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lund-Kennedy Endoscopic Score
Time Frame: Baseline, Day 29, and Day 42
Lund-Kennedy Endoscopic Score. Minimum value 0 (normal), maximum value 20 (most severe inflammation). Higher scores mean a worse outcome. This scale assesses polyps, oedema, discharge, scarring, and crusting.
Baseline, Day 29, and Day 42
Change in SNOT-22 Score
Time Frame: Baseline, Day 29, Day 42, and Day 90
Sino-Nasal Outcome Test-22 (SNOT-22) Score. Minimum value 0 (no symptoms), maximum value 110 (worst possible symptoms). Higher scores mean a worse outcome.
Baseline, Day 29, Day 42, and Day 90
Change in VAS Symptom Score (nasal congestion, rhinorrhoea, facial pressure, smell loss)
Time Frame: Daily during treatment (Days 1-28) and follow-up up to Day 90
Visual Analog Scale (VAS) for nasal symptoms. Minimum 0 (no distress), maximum 10 (worst imaginable distress). Higher scores mean a worse outcome.
Daily during treatment (Days 1-28) and follow-up up to Day 90
Response Rate (SNOT-22 improvement ≥15 points or ≥50%)
Time Frame: Day 29
Day 29
Change in Quality of Life (SF-36)
Time Frame: Baseline and Day 29
36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100. Higher scores indicate better quality of life.
Baseline and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAHMU-CRS-AP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single-centre exploratory study with a small sample size (N=108). The data contain sensitive participant information and are subject to local privacy regulations. No formal data sharing agreement is planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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