Asthma in ChildrenNCT06851403
The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study
An observational study of Asthma in Children, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
About this study
Official title: 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.
- Conditions
- Asthma in Children
- Being tested
- Dupilumab
- Keywords
- type 2 inflammation, asthma, dupilumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks
| Study group | Role | What they receive |
|---|---|---|
| Case group | Not described Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
forced expiratory volume in one second
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
FVC
forced vital capacity
Measured: 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
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
PEF
peak expiratory flow
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
Secondary outcomes (4)
FeNO
fraction of exhaled nitric oxide
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
blood EOS
blood eosinophil count
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
percentage of sputum eosinophils
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
TIgE
serum total immunoglobulin E
Measured: From enrollment to the end of treatment through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start30 Jan 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851403
- Sponsor's protocol ID
- GuangzhouIRD -LSUN
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Dupilumab in Children with Severe Asthma in China: a Real-world Study
- ClinicalTrials.gov ID
- NCT06851403
- Acronym / sponsor ID
- GuangzhouIRD -LSUN
- Conditions
- Asthma in Children
- Keywords
- type 2 inflammation, asthma, dupilumab
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Drug: Dupilumab |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumabinitial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks | Drug | Case group |
Primary outcome
FEV1
Time frame: From enrollment to the end of treatment through study completion, an average of 1 year
forced expiratory volume in one second
FVC
Time frame: From enrollment to the end of treatment through study completion, an average of 1 year
forced vital capacity
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
PEF
Time frame: From enrollment to the end of treatment through study completion, an average of 1 year
peak expiratory flow
4 secondary outcomes
FeNO
Time frame: 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
percentage of sputum eosinophils
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: From enrollment to the end of treatment through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.