Chronic Rhinosinusitis Without Polyps
Conditions
Keywords
Chronic Rhinosinusitis, Acute Exacerbation, Thermosensitive Gel, Nasal Spray, Exosomes, Interferon alpha-2b, Antiviral, Anti-inflammatory, Randomized Controlled Trial, Azelastine
Brief 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.
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.
Interventions
DRUGExosomes, 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.
DRUGAzelastine and Interferon alpha-2b
Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10\^5 IU/mL.
Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The active and placebo sprays are identical in appearance (container, volume, color, and viscosity). An independent, unblinded pharmacist prepares the sprays according to the randomisation list and does not participate in any subsequent clinical evaluation or data analysis.
Intervention model description
Participants are randomly assigned in a 1:1:1 ratio to three parallel groups: Group A (triple combination: exosomes + azelastine + interferon), Group B (dual combination: azelastine + interferon), and Group C (placebo: gel matrix only). All groups receive the same thermosensitive gel base, identical volume, frequency, and route of administration. The study is double-blind (participants, care providers, investigators, and outcomes assessors).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lund-Kennedy Endoscopic Score | 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. |
| Change in SNOT-22 Score | 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. |
| Change in VAS Symptom Score (nasal congestion, rhinorrhoea, facial pressure, smell loss) | 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. |
| Response Rate (SNOT-22 improvement ≥15 points or ≥50%) | Day 29 | — |
| Change in Quality of Life (SF-36) | 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. |
Contacts
CONTACTWenjie Ren, MD, PhD
CONTACTWenfa Yu, MD, PhD
Outcome results
None listed