Seasonal allergic rhinitis
Conditions
Interventions
high dose group:high dose of omalizumab
low dose group:low dose of omalizumab
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Between 18 and 65 years of age, regardless of gender; 2.In the past 2 years, the patient had typical symptoms of runny nose, sneezing, and eye itching appeared in spring or autumn, and the effect of oral antihistamines was not good; 3.Intradermal tests of spring or autumn pollens showed that the diameter of wheals was greater than 10mm, the level of specific IgE to spring or autumn pollen was higher than 0.7 KUA/L, and 30 < total IgE < 100 IU/ml. 4.Voluntarily sign the informed consent form and be able to cooperate with the completion of various examinations and follow-up visits;
Exclusion criteria
Exclusion criteria: 1.Allergy to omalizumab, therapeutic drug excipients, or other biosimilars, or history of severe drug allergy, anaphylactic shock; 2.Those with severe cardiovascular, liver, kidney and other systemic diseases that may affect research results or be at risk for treatment; 3.Those who are receiving other treatments that may affect immune function (e.g., immunosuppressants, biologics, etc.) or plan to receive such treatments during the study period; 4.Pregnant or lactating women; 5.People with mental illness or cognitive impairment who are unable to understand and cooperate with the research protocol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rhinoconjunctivitis symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rhinoconjunctivitis Quality of Life Questionnaire score;Allergic Rhinitis Control Test score;symptomatic medicine score;safety evaluation;Nasal resistance;Inflammation level of nasal secretion; | — |
Countries
China
Contacts
Public ContactLisha Li
Peking Union Medical College Hospital
Outcome results
None listed