allergic rhinitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18-65 years old (including boundary value); 2) No gender limitation; 3) Meet the diagnostic criteria of allergic rhinitis in the Chinese Guidelines for the Diagnosis and Treatment of Allergic rhinitis (Revised Edition 2022) : (1) Symptoms: two or more symptoms, such as paroxysmal sneezing, watery nose, nasal itching and nasal congestion, persist or accumulated for more than 1 hour per day, may be accompanied by eye symptoms such as tearing, eye itching and eye redness; ? Physical examination: bilateral nasal mucosa pale, swollen, lower turbinate edema, nasal cavity with watery secretions; Allergen testing: At least one allergen is positive for SPT and/or clear specific IgE, or positive for nasal stimulation test. 4) Nasal symptom score (TNSS)=8 points during screening; 5) Voluntarily sign informed consent, and agree to participate in all visits, examinations and treatments as required by the experimental protocol.
Exclusion criteria
Exclusion criteria: 1) Allergic to any component of the test drug; 2) Nasal polyps or severe deviated septum; Infectious paranasal sinusitis, otitis media; 3) Those with bronchiectasis, tuberculosis, COPD or other respiratory diseases and those with respiratory infections within 14 days; 4) Patients with serious cardiovascular and hematological diseases, and ALT=2ULN or AST=2ULN or Cr= 1.5ULN; 5) Patients with malignant tumors; 6) Pregnant or lactating women; Or if the subject or his or her partner is unable to use the prescribed contraceptive method within 3 months from the date of signing the informed consent to the last dose. 7) Patients with the following combined drug use before screening: a. Immunotherapy within 180 days; b. Oral or nasal inhalation or intraocular use of corticosteroids within 14 days; c. Eye drops or oral chromones within 14 days; d. Oral antihistamine within 14 days, nasal antihistamine within 10 days, eye drops of antihistamine within 3 days; e. Use anti-leukotriene drugs within 7 days; f. Use vasoconstrictors and anticholinergics within 7 days; 8) Participants in any other clinical trial within 2 months prior to screening; 9) According to the judgment of the investigator, those who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total nasal symptom scores (TNSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| total ocular symptom scores (TOSS);hinoconjunctivitis quality of life questionnaire (RQLQ); | — |
Countries
China
Contacts
the First Affiliated Hospital of Xi 'an Jiaotong University Yulin Hospital