Asthma in Children
Conditions
Keywords
type 2 inflammation, asthma, dupilumab
Brief summary
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
DRUGDupilumab
initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PEF | From enrollment to the end of treatment through study completion, an average of 1 year | peak expiratory flow |
| FEV1 | From enrollment to the end of treatment through study completion, an average of 1 year | forced expiratory volume in one second |
| FVC | From enrollment to the end of treatment through study completion, an average of 1 year | forced vital capacity |
| FEV1/FVC | From enrollment to the end of treatment through study completion, an average of 1 year | ratio of forced expiratory volume in onesecond to forced vital capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FeNO | From enrollment to the end of treatment through study completion, an average of 1 year | fraction of exhaled nitric oxide |
| blood EOS | From enrollment to the end of treatment through study completion, an average of 1 year | blood eosinophil count |
| percentage of sputum eosinophils | From enrollment to the end of treatment through study completion, an average of 1 year | — |
| TIgE | From enrollment to the end of treatment through study completion, an average of 1 year | serum total immunoglobulin E |
Countries
China
Outcome results
None listed