The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study

Guangzhou Institute of Respiratory Disease

Status: Invitation-only

Conditions: Asthma in Children

Treatments: Drug: Dupilumab

Study type: Observational

Funder types: Other

Identifiers

NCT06851403

GuangzhouIRD -LSUN

Details and patient eligibility

About

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.

Enrollment: 213 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

213 participants in 1 patient group

Case group

Treatment:

Drug: Dupilumab