The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab.
- Who it may be relevant to
- Registry conditions: Asthma in Children. Basic parameters: 4 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effectiveness and Safety of Dupilumab in Children with Severe Asthma in China: a Real-world Study
Overview
Observe the changes of type II inflammation markers, lung function, and symptom scores in asthmatic patients aged 6 to 14 during the use of dupilumab to analyze its efficacy.
Interventions
- Drug Dupilumab
initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks
Primary outcome measures
- FEV1 [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- FVC [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- FEV1/FVC [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- PEF [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
Secondary outcome measures (4)
- FeNO [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- blood EOS [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- percentage of sputum eosinophils [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
- TIgE [Time frame: From enrollment to the end of treatment through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
Enrolled patients were required to have been on regular ICS-LABA therapy for at least 3-6 months without adequate control. The attending physician evaluated these patients as having type 2 inflammatory asthma based on factors such as FeNO (fractional exhaled nitric oxide) levels ≥ 20, sputum eosinophils (EOS) percentage ≥ 2%, and/or blood EOS count ≥ 300/μl. All children were prescribed with dupilumab during the study period.
Exclusion criteria
Patients with conditions other than asthma receiving treatment with dupilumab, individuals currently using other biologics or undergoing sublingual or subcutaneous immunotherapy, active parasitic infections, and children with immunodeficiency were excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Guangzhou institute of respiratory disease — Guangzhou
Identifiers
NCT: NCT06851403 · GuangzhouIRD -LSUN