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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FeNO | fraction of exhaled nitric oxide | From enrollment to the end of treatment through study completion, an average of 1 year |
| blood EOS | blood eosinophil count |
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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.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou institute of respiratory disease | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| 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 | serum total immunoglobulin E | From enrollment to the end of treatment through study completion, an average of 1 year |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |