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

NCT07635459 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HAHMU-CRS-AP-001
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Rhinosinusitis Without Polyps

Keywords

Chronic Rhinosinusitis; Acute Exacerbation; Thermosensitive Gel; Nasal Spray; Exosomes; Interferon alpha-2b; Antiviral; Anti-inflammatory; Randomized Controlled Trial; Azelastine

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Change in Lund-Kennedy Endoscopic Score

  Baseline, Day 29, and Day 42

• Change in SNOT-22 Score

  Baseline, Day 29, Day 42, and Day 90

• 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

• Response Rate (SNOT-22 improvement ≥15 points or ≥50%)

  Day 29

• Change in Quality of Life (SF-36)

  Baseline and Day 29

Study Arms (3)

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.

Drug: Exosomes, Azelastine, and Interferon alpha-2b

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.

Drug: Azelastine and Interferon alpha-2b

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.

Drug: Placebo Gel Matrix

Interventions

Placebo Gel Matrix DRUG

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

Also known as: Blank thermosensitive gel

Placebo (Gel Matrix Only)

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.

Also known as: Triple combination spray

Triple Combination (Exosomes + Azelastine + Interferon)

Azelastine and Interferon alpha-2b DRUG

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

Also known as: Dual combination spray

Dual Combination (Azelastine + Interferon)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Related Publications (6)

• 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.

  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.

  PMID: 32029601 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.

  PMID: 35927511 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.

  PMID: 30776860 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.

  PMID: 32077450 BACKGROUND

MeSH Terms

Interventions

azelastine; Introns

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Central Study Contacts

Wenjie Ren, MD, PhD

CONTACT

86+13837310327; 13937354075@163.com

Wenfa Yu, MD, PhD

CONTACT

86+15516510606; yuwenfa197288@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share