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

NCT06851403 | Enrolling By Invitation DMC

• 1 other identifier: GuangzhouIRD -LSUN
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

type 2 inflammation; asthma; dupilumab

Outcome Measures

Primary Outcomes (4)

• FEV1

  forced expiratory volume in one second

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

• FVC

  forced vital capacity

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

• FEV1/FVC

  ratio of forced expiratory volume in onesecond to forced vital capacity

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

• PEF

  peak expiratory flow

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

Secondary Outcomes (4)

• FeNO

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

• blood EOS

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

• percentage of sputum eosinophils

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

• TIgE

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

Study Arms (1)

Case group

Drug: Dupilumab

Interventions

Dupilumab DRUG

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

Case group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangzhou Institute of Respiratory Disease

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: February 28, 2025
• Study Start: January 30, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)