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Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responder group | The improvement in ACT score ≥ 3,or pre-treatment ACT score < 20 and a post-treatment ACT score ≥ 20;The GETE score was excellent or good. |
| |
| No-Responder group | The improvement in ACT score < 3;The GETE score was moderate,poor and worse. |
| |
| Good adherence | The proportion of patients whose missed doses of omalizumab fewer than 10% of all doses over the1 year, we think these patients were good adherence. |
| |
| Poor adherence | the proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgE monoclonal antibody | Drug | omalizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Test (ACT) | The responder in ACT was required to meet any of the following conditions:(a) an improvement in ACT score ≥ 3 (MID); and (b) a pre-treatment ACT score < 20 (poor or poorly controlled asthma) and a post-treatment ACT score ≥ 20 (well controlled asthma). | Baseline, up to16weeks,24weeks and 1year of treatment. |
| Global Evaluation of Treatment Effectiveness (GETE) | Global Evaluation of Treatment Effectiveness (GETE) score after omalizumab treatment. The responder in GETE is score of "excellent" or"good" after treatment. | Baseline, up to16weeks,24weeks and 1year of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 second(FEV1) | Pre-bronchodilators FEV1 . | Baseline, up to 16weeks,24weeks and 1year of treatment. |
| FEV1/predicted%. | Pre-bronchodilators FEV1/predicted%. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe allergic asthma who received omalizumab at the First Affiliated Hospital with Nanjing Medical University from 2018 to 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linfu Zhou, Doctor | Contact | 86+13611573618 | linfu.zhou@126.com | |
| Xuejun Zhang, Master | Contact | 86+13704726254 | zxj1301@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linfu zhou | Recruiting | Nanjing | Jiangsu | 210000 | China |
Protect patient privacy
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline, up to 16weeks,24weeks and 1year of treatment. |
| Forced Vital Capacity (FVC) | Pre-bronchodilators FVC | Baseline, up to16weeks,24weeks and 1year of treatment. |
| FEV1/FVC. | Pre-bronchodilators FEV1/FVC. | Baseline, up to16weeks,24weeks and 1year of treatment. |
| Number of Acute Exacerbations(AE) | Number of acute exacerbations 1 year before omalizumab treatment,and up to16weeks,24weeks and 1year of treatment. | up to16weeks,24weeks and 1year of treatment. |
| Oral glucocorticoid dosage | Oral glucocorticoid dosage before and after omalizumab treatment | up to16weeks,24weeks and 1year of treatment. |
| Good adherence | Adherence to omalizumab treatment in this study was assessed by examining the rates of missed doses,the proportion of patients who missed fewer than 10% of all doses over 1 years was good adherence. | 1 year |
| Poor adherence | Adherence to omalizumab treatment in this study was assessed by examining the rates of missed doses,the proportion of patients who missed at least 10% of all doses over 1 year was poor adherence. | 1 year |
| Adverse events | Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% | up to16weeks,24weeks and 1year of treatment. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |