allergic rhinitis
Conditions
Interventions
Treatment group 1:Azelastine Hydrochloride Nasal Spray (No. 1) + Azelastine Hydrochloride Nasal Spray (No. 2)
Treatment group 2:Azelastine Hydrochloride Nasal Spray (No. 1) + Azelastine Hydrochloride Nasal Spray Placebo (No. 2)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1.Age 2~11 years old, male or female; 2.Clinical symptoms: sneezing, watery discharge, nasal congestion, nasal itching and other symptoms appear more than 2 (including 2 items), and the symptoms last or accumulate for more than 1h per day. It may be accompanied by ocular symptoms such as itchy eyes and conjunctival hyperemia; 3.Signs: anterior rhinoscopy reveals pale, edema, nasal watery discharge on the nasal mucosa; 4.At least 1 allergen SPT or serum-specific IgE positive within 1 year before enrollment, and perennial allergen population; Skin prick test (SPT): skin prick using standardized allergen reagents with a positive reaction of (++) or more for at least 1 allergen. (Requirements: ? Compared with the negative control, the average diameter of the wheal =3mm was judged to be positive for SPT; ? wheal diameter = (longest diameter + vertical diameter of longest diameter)/2;? skin reaction index SI = allergen wheals diameter / positive control wheals diameter; ? Level: +:0.3=SI100kU/L. 5.Duration: Symptoms = 4 days/week and = 4 weeks; 6.Degree of symptoms: One or more symptoms that cause sleep disturbances and affect life/work/study; 7. The total score of nasal symptoms VAS = 20 points (nasal symptoms include runny nose, nasal congestion, nasal itching, and sneezing, and the VAS score is on a 0-10 scale with a total score of 0-40); 8.At the time of screening, subjects or their guardians can master the correct nasal spray delivery technique; 9.The subject's guardian has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with non-allergic rhinitis; 2.Patients with other nasal diseases, such as acute and chronic sinusitis, nasal polyps, mycotic sinusitis, deviated nasal septum, atrophic rhinitis, nasal tumors, etc; 3.Patients with allergic rhinitis who have received or are undergoing immunotherapy; 4.Patients who have undergone nasal surgery or have nasal trauma within 3 months; 5.Patients who have previously used azalex hydrochloride nasal spray and do not respond well; 6.Patients with any diseases in which it is necessary to use "concomitant contraindications"; 7.Patients with insufficient number of days of discontinuation of "concomitant contraindications"; 8.Patients with asthma attacks; 9.Those with a history of intolerance or allergy to any of the drugs or their excipients in the program; 10.Participated in other clinical studies within 6 months prior to the start of the study; 11.Guardians of participants are unwilling to sign written informed consent or follow study protocols; 12.Other reasons why the researchers deemed it inappropriate to be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal symptoms throughout the day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daytime and nocturnal nasal symptoms;Individual nasal symptoms;Ocular symptoms;Itchy eyes;Appearance morphology of nasal mucosa; | — |
Countries
China
Contacts
Public ContactJuan MENG
West China Hospital of Sichuan University
Outcome results
None listed