Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Combination (Exosomes + Azelastine + Interferon) | Experimental | 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. |
|
| Dual Combination (Azelastine + Interferon) | Active Comparator | 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. |
|
| Placebo (Gel Matrix Only) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosomes, Azelastine, and Interferon alpha-2b | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to day 90 (long-term follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 29, and Day 42 |
| Change in SNOT-22 Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Ren, MD, PhD | Contact | 86+13837310327 | 13937354075@163.com | |
| Wenfa Yu, MD, PhD | Contact | 86+15516510606 | yuwenfa197288@aliyun.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lee JT, Li Z, Chiu AG. Staphylococcus aureus biofilms in chronic rhinosinusitis. Current Opinion in Otolaryngology & Head and Neck Surgery. 2022;30(1):25-32. doi: 10.1097/MOO.0000000000000771. | ||
| Background | Gurwitz D. Human interferon alpha-2b: a topical antiviral for the treatment of COVID-19 and other respiratory viral infections. Drug Development Research. 2020;81(7):783-785. doi: 10.1002/ddr.21718. | ||
| 32029601 | Background | Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977. | |
| 35927511 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
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.
|
| Azelastine and Interferon alpha-2b | Drug | Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10^5 IU/mL. |
|
|
| Placebo Gel Matrix | Drug | Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only. |
|
|
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) | 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%) | 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. | Baseline and Day 29 |
| Background |
| Buzas EI. The roles of extracellular vesicles in the immune system. Nat Rev Immunol. 2023 Apr;23(4):236-250. doi: 10.1038/s41577-022-00763-8. Epub 2022 Aug 4. |
| 30776860 | Background | Subspecialty Group of Rhinology, Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery; Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018)]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2019 Feb 7;54(2):81-100. doi: 10.3760/cma.j.issn.1673-0860.2019.02.001. No abstract available. Chinese. |
| 32077450 | Background | Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600. |
| ID | Term |
|---|---|
| C020976 | azelastine |
| D007438 | Introns |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
Not provided
Not provided