Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis (CRS)
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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
108
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Wenjie Ren, MD, PhD
- 电话号码：86+13837310327
- 邮箱：13937354075@163.com
研究联系人备份
- 姓名：Wenfa Yu, MD, PhD
- 电话号码：86+15516510606
- 邮箱：yuwenfa197288@aliyun.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
其他名称：
|
|
有源比较器：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.
|
Thermosensitive gel nasal spray containing azelastine hydrochloride 0.1% and interferon α-2b 1×10^5 IU/mL.
其他名称：
|
|
安慰剂比较：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.
|
Thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) only.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with Treatment-Related Adverse Events
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Lund-Kennedy Endoscopic Score
大体时间：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
大体时间：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)
大体时间：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%)
大体时间：Day 29
|
Day 29
|
|
|
Change in Quality of Life (SF-36)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年6月30日
研究注册日期
首次提交
2026年5月30日
首先提交符合 QC 标准的
2026年6月7日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月9日
上次提交的符合 QC 标准的更新
2026年6月7日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- HAHMU-CRS-AP-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.