Moderate to Severe Allergic Asthma
Conditions
Keywords
asthma, omalizumab, allergy, IgE
Brief summary
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.
Interventions
DRUGIgE monoclonal antibody
omalizumab
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Moderate-to-severe asthma patients aged ≥ 14 years who met the criteria of the Asthma Group of the Chinese Thoracic Society (Guidelines for bronchial asthma prevention and management, 2020 edition)-moderate asthma was defined as those who could achieve complete control using grade 3 therapy, and severe asthma was defined as fully or incompletely controlled with grade 4 or 5 asthma medications. * History of asthma exacerbations induced by allergen exposure , elevated total serum IgE and positive specific IgE test or positive skin prick test. * Treatment with omalizumab.
Exclusion criteria
* Hypersensitivity to the active ingredient of omalizumab. * Asthma exacerbation in the baseline. * Combined with diseases that severely affect ventilation,such as bronchiectasis, lung cancer, allergic bronchopulmonary aspergillosis (ABPA), acute respiratory infections, chronic obstructive pulmonary disease (COPD),etc. * Receiving other biologically targeted therapies (e.g., anti-interleukin (IL)-5 monoclonal antibody, anti-IL-4 monoclonal antibody, anti-IL-13 monoclonal antibody, anti-IL-5 receptor α (IL-5Rα) monoclonal antibody, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test (ACT) | Baseline, up to16weeks，24weeks and 1year of treatment. | 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). |
| Global Evaluation of Treatment Effectiveness (GETE) | Baseline, up to16weeks，24weeks and 1year of treatment. | Global Evaluation of Treatment Effectiveness (GETE) score after omalizumab treatment. The responder in GETE is score of excellent orgood after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1 second（FEV1) | Baseline, up to 16weeks，24weeks and 1year of treatment. | Pre-bronchodilators FEV1 . |
| FEV1/predicted%. | Baseline, up to 16weeks，24weeks and 1year of treatment. | Pre-bronchodilators FEV1/predicted%. |
| Forced Vital Capacity （FVC） | Baseline, up to16weeks，24weeks and 1year of treatment. | Pre-bronchodilators FVC |
| Poor adherence | 1 year | 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. |
| Number of Acute Exacerbations（AE） | up to16weeks，24weeks and 1year of treatment. | Number of acute exacerbations 1 year before omalizumab treatment,and up to16weeks，24weeks and 1year of treatment. |
| Oral glucocorticoid dosage | up to16weeks，24weeks and 1year of treatment. | Oral glucocorticoid dosage before and after omalizumab treatment |
| Good adherence | 1 year | 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. |
| FEV1/FVC. | Baseline, up to16weeks，24weeks and 1year of treatment. | Pre-bronchodilators FEV1/FVC. |
| Adverse events | up to16weeks，24weeks and 1year of treatment. | Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% |
Countries
China
Contacts
Primary ContactLinfu Zhou, Doctor
Backup ContactXuejun Zhang, Master
Outcome results
None listed