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

• Conditions: Asthma in Children
• Interventions: Drug: Dupilumab

• Registration Number: NCT06851403
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-30
• Study First Submitted: 2024-10-03
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 213

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Dupilumab	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
FeNO	From enrollment to the end of treatment through study completion, an average of 1 year	fraction of exhaled nitric oxide
TIgE	From enrollment to the end of treatment through study completion, an average of 1 year	serum total immunoglobulin E
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

Trial Locations

Locations (1)

Guangzhou institute of respiratory disease; 🇨🇳 Guangzhou, Guangdong, China