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Chronic Rhinosinusitis Without PolypsEarly Phase 1CRSNCT07635459

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

A Early Phase 1 study testing Exosomes, Azelastine, and Interferon alpha-2b and Azelastine and Interferon alpha-2b in people with Chronic Rhinosinusitis Without Polyps, run by The First Affiliated Hospital of Xinxiang Medical College.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Rhinosinusitis Without Polyps
What is being tested?
Exosomes, Azelastine, and Interferon alpha-2b and Azelastine and Interferon alpha-2b
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 30 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wenjie Ren, MD, PhD contact

86+13837310327

13937354075@163.com

Wenfa Yu, MD, PhD contact

86+15516510606

yuwenfa197288@aliyun.com

About this study

Official title: 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.

Read the 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.

Being tested
Exosomes, Azelastine, and Interferon alpha-2b, Azelastine and Interferon alpha-2b, Placebo Gel Matrix
Keywords
Chronic Rhinosinusitis, Acute Exacerbation, Thermosensitive Gel, Nasal Spray, Exosomes, Interferon alpha-2b, Antiviral, Anti-inflammatory, Randomized Controlled Trial, Azelastine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exosomes, Azelastine, and Interferon alpha-2bDrug

    Also called Triple combination spray

    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

    Also called Dual combination spray

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

  • Placebo Gel MatrixDrug

    Also called Blank thermosensitive gel

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

Study groups in NCT07635459
Study groupRoleWhat they receive
Triple Combination (Exosomes + Azelastine + Interferon)ExperimentalThermosensitive 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.
Receives: Drug: Exosomes, Azelastine, and Interferon alpha-2b
Dual Combination (Azelastine + Interferon)Active comparatorThermosensitive 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.
Receives: Drug: Azelastine and Interferon alpha-2b
Placebo (Gel Matrix Only)Placebo comparatorBlank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) without active ingredients. Two sprays per nostril, twice daily for 28 days.
Receives: Drug: Placebo Gel Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, Day 29, and Day 42

  2. 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.

    Measured: Baseline, Day 29, Day 42, and Day 90

  3. 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.

    Measured: Daily during treatment (Days 1-28) and follow-up up to Day 90

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

    Measured: Day 29

  5. 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.

    Measured: Baseline and Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635459
Sponsor's protocol ID
HAHMU-CRS-AP-001
Acronym
CRS
Status last verified
May 2026
First submitted
30 May 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

  • Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.

    PubMed 32029601

  • 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.

    PubMed 35927511

  • 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.

    PubMed 30776860

  • 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.

    PubMed 32077450

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Exosomes, Azelastine, and Interferon alpha-2b and Azelastine and Interferon alpha-2b in people with Chronic Rhinosinusitis Without Polyps, run by The First Affiliated Hospital of Xinxiang Medical College.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenjie Ren, MD, PhD (86+13837310327, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Related Adverse Events (time frame: From baseline up to day 90 (long-term follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635459, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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