Clinical Trials in China / NCT06851403
Enrolling by invitation
Observational
The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study
NCT06851403 · tracked via the Priya Life Science China tracker
Condition(s) studied
Asthma in Children
Investigational drug(s) / intervention(s)
Dupilumab: initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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 - PEF — From enrollment to the end of treatment through study completion, an average of 1 year
peak expiratory flow
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangzhou institute of respiratory disease | Guangzhou | Guangdong |
On this site
📄 Dupixent (dupilumab) drug profile →More Guangzhou Institute of Respiratory Disease trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06851403 on ClinicalTrials.gov ↗ ← All trials in China