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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-30

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma in Children

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Case group

Dupilumab

Intervention Type DRUG

initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks

Interventions

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Dupilumab

initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No