seasonal allergic rhinitis
Conditions
Interventions
Test group:budesonide nasal spray
Reference group:budesonide nasal spray
Placebo group:placebo
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-65 years old; 2. Female subjects should be non-pregnant, non-breastfeeding and willing to take contraceptive measures; 3. Patients with moderate to severe seasonal allergic rhinitis, medical history >=1 year. A positive test for relevant specific allergens (e.g., allergen skin test, serum-specific IgE); 4. The pre-dose rTNSS >=6 points before administration on the first day of the run-in period and the treatment period; Mean baseline rTNSS >=6 points; 5. Those who agree to participate in this clinical trial and sign an informed consent; 6. The ability to understand and cooperate during the experiment is better, and the patient can use nasal spray correctly after receiving training.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to budesonide or any of its excipients, or have proven ineffective in the treatment of budesonide or other glucocorticoid drugs in the past. 2. Patients with asthma who need long-term treatment. 3. People with active or inactive tuberculosis infection, untreated local or systemic fungal, bacterial, viral or parasitic infection. 4. Presence of glaucoma, cataracts, herpes simplex of the eye, infectious conjunctivitis, or other eye infection 5. Presence of any nasal mucosal erosion, nasal septal ulcers, or septum perforation on focused nasal examination at screening or randomization. 6. Those who have undergone sinus surgery within 3 months or have nasal trauma that has not healed completely. 7. People with other nasal diseases that may affect intranasal drug deposition. 8. Patients with respiratory infections requiring antibiotic treatment within 4 weeks before screening. 9. Severe liver or kidney disease, or abnormal liver and kidney function tests. 10. Presence or history of any clinically significant condition that, in the opinion of the investigator, would compromise the safety of the subject or the conduct of the study. 11. Placebo responders during the run-in period. 12. Alcohol addicts or drug addicts in the past 5 years. 13. Pregnant or lactating women, and male subjects (or their partners) or female subjects who have a pregnancy plan during the entire trial period and within 3 months after the end of the study. 14. Participated in other clinical trials within 3 months before the screening period and used study drugs. 15. According to the researcher's judgment, the subject may have an impact on the compliance of any aspect of the program due to physical, cultural level, or geographic location. 16. The investigator believes that there are any circumstances that may affect the subjects informed consent or follow the trial protocol, or the subjects participation in the trial may affect the trial results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from the baseline mean rTNSS to the treatment mean rTNSS; | — |
Countries
China
Contacts
Public ContactDehui Wang
The Eye & ENT Hospital of Fudan University
Outcome results
None listed