The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study
February 26, 2025 updated by: LI-HONG SUN, Guangzhou Institute of Respiratory Disease
The Effectiveness and Safety of Dupilumab in Children with Severe 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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
213
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Guangzhou Institute of Respiratory Disease
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Case group
|
initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
forced expiratory volume in one second
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
FVC
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
forced vital capacity
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
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
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
PEF
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
peak expiratory flow
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FeNO
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
fraction of exhaled nitric oxide
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
blood EOS
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
blood eosinophil count
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
percentage of sputum eosinophils
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
|
|
TIgE
Time Frame: From enrollment to the end of treatment through study completion, an average of 1 year
|
serum total immunoglobulin E
|
From enrollment to the end of treatment through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2022
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
October 3, 2024
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouIRD -LSUN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.