Children's allergic asthma
Conditions
Interventions
Experimental group:Omalizumab treatment
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 6 and 18 years old (inclusive), any gender; 2. Diagnosed with allergic asthma with type II inflammatory comorbidity; 3. Children who have not achieved good control after 3 months of regular ICS/LABA inhalation treatment (good control is defined as none of the following: daytime symptoms >2 times/week; awakened at night due to asthma; use of rescue medication >2 times/week; activity limitation due to asthma); 4. Voluntarily sign the informed consent, understand the requirements for filling out the diary card, and record daily symptoms accurately and on time during the study, voluntarily cooperate with completing the trial according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Children who are allergic to omalizumab or excipients of the treatment drug (active ingredient: omalizumab; excipients include sucrose, L-histidine hydrochloride, L-histidine hydrochloride monohydrate, and polysorbate 20); 2. Children in acute exacerbation of asthma, acute bronchospasm, or status asthmaticus; 3. Children with liver damage, kidney damage, or autoimmune diseases; 4. Children at high risk of parasitic infections such as worms; 5. Other situations deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function test;Total serum IgE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Childhood Asthma Control Test (C-ACT);Pediatric Asthma Quality of Life Questionnaire (PAQLQ);visual analogue scale;Pediatric Rhinconjunctivitis quality of life questionnnaire;Dermatology Life Quality Index;eczema area and severity index;Urticaria Activity Score; | — |
Countries
China
Contacts
Public ContactShi Ruiming
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed