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

Early Phase 1Not Yet RecruitingNCT07635459

The First Affiliated Hospital of Xinxiang Medical College108 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Interventions

Exosomes, Azelastine, and Interferon alpha-2bDRUG

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-2bDRUG

Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10\^5 IU/mL.

Placebo Gel MatrixDRUG

Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants with Treatment-Related Adverse Events

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.

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

Secondary Outcomes

Change in Lund-Kennedy Endoscopic Score

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.

Time frame: Baseline, Day 29, and Day 42

Change in SNOT-22 Score

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.

Time frame: Baseline, Day 29, Day 42, and Day 90

Change in VAS Symptom Score (nasal congestion, rhinorrhoea, facial pressure, smell loss)

Visual Analog Scale (VAS) for nasal symptoms. Minimum 0 (no distress), maximum 10 (worst imaginable distress). Higher scores mean a worse outcome.

Time frame: 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

Change in Quality of Life (SF-36)

36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100. Higher scores indicate better quality of life.

Time frame: Baseline and Day 29