Allergic rhinitis
Conditions
Interventions
Low dose group:5×10^8 particles exosome+conventional treatment
Medium dose group:1×10^9 particles exosome+conventional treatment
High dose group:2×10^9 particles exosome+conventional treatment
Control group:Physiological saline+conventional treatment
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, inclusive, regardless of gender. 2. rTNSS score >= 6 and retrospective nasal congestion score >= 2. 3. Diagnosed with moderate to severe allergic rhinitis, with a confirmed history >= 2 years, and a positive result to any allergen in either skin prick test (SPT) or serum-specific IgE (sIgE) test. 4. Women of childbearing potential and all male participants must commit to using at least one effective contraceptive method from signing the informed consent form until 1 month after the last dose of the trial drug. 5. Willing to sign the informed consent form and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Active or inactive TB infection; 2. Patients with moderate to severe asthma; 3. Active pulmonary disease or infection within 4 weeks before screening; 4. Patients who underwent nasal or sinus surgery within 3 months before screening or who had a nasal wound that had not yet healed; 5. Any nasal mucosal erosion, nasal septal ulcer, nasal septal perforation or other nasal diseases that may affect nasal drug deposition according to the investigator's judgment, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc 6. Herpes simplex or other ocular infections (except seasonal allergic conjunctivitis); 7. Facial or systemic fungal, bacterial, viral or parasitic infections or oral infections that have not been cured and require continuous treatment within 4 weeks before screening; 8. Patients with serious diseases of the central nervous system, respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrine system or blood system that may affect the efficacy and safety of the subjects; 9. Positive for hepatitis B surface antigen, hepatitis C virus antibody, syphilis serum antibody or HIV antibody; 10. Patients who received the following medications (including but not limited to the following) within the following limited time period before the first dose: nasal or systemic decongestants, anticholinergic agents within 3 days; Antihistamines such as cetirizine, fexofenadine and loratadine are used within 5 days; Systemic glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists were used for 4 weeks or 2 weeks. Use of anti-allergic Chinese herbal medicine within 2 weeks; 11. JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except the rescue drug loratadine required during the treatment period), leukotriene receptor antagonists, mast cell membrane stabilizer (including cromolynate sodium, nidoate sodium, tetrazolium setanone, nedocromil sodium, pipyrilast potassium and tranilast, etc.), and antibiliary drugs could not be stopped during the trial Alkali medicine, anti-allergic Chinese herbal medicine and nasal irrigation; 12. Patients who received desensitization treatment or immunotherapy within 6 months before screening; 13. Those who are known or judged by the investigator to be likely to have allergic reactions to the active ingredient or excipients of the investigational drug; 14. Patients who could not tolerate aerosol administration in the past; 15. Subjects who participated in other clinical studies of investigational drugs or medical devices within 3 months before screening; 16. The female subjects were lactating or pregnant at the time of screening; Subjects of childbearing age (male or female) who plan to become pregnant, breastfeed, or plan to donate sperm/eggs during the study or within 1 month after the study; 17. Other circumstances considered by the investigator to be inappropriate for participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rTNSS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory factors;VAS score;ROLQ score; | — |
Countries
China
Contacts
Public ContactDi Zhang, Fenfang Wu
Shenzhen Third People's Hospital
Outcome results
None listed