Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06851403

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

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

Primary outcomes

  1. FEV1

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    forced expiratory volume in one second

  2. FVC

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    forced vital capacity

  3. FEV1/FVC

    Time frame: 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

  4. PEF

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    peak expiratory flow

Secondary outcomes

  1. FeNO

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    fraction of exhaled nitric oxide

  2. blood EOS

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    blood eosinophil count

  3. percentage of sputum eosinophils

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

  4. TIgE

    Time frame: From enrollment to the end of treatment through study completion, an average of 1 year

    serum total immunoglobulin E

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.