Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

Study Overview
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Brief Summary
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The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.

Detailed Description
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This non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice. This study was designed to use secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -<12 years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction.

Official Title
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A Retrospective Multicenter Study for Assessment of the Effectiveness and Safety of Omalizumab in Children With Allergic Asthma in a Real-world Setting in China

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 6 -<12 years Diagnosed with allergic asthma and could be treated using omalizumab. Comorbidities included allergic rhinitis, atopic dermatitis, nasal polyp, chronic urticaria, and food allergy Received omalizumab during the identification period Had at least one documented follow-up data after omalizumab treatment Provided informed consent if required by ethics committee (EC) of hospital Exclusion Criteria: Current participation in a clinical trial of any investigational treatment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omalizumab<br>Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab | Drug: Omalizumab<br>* Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who responded to omalizumab | The responders were defined as patients with: Investigator's Global Evaluation of Treatment Effectiveness (GETE) are Excellent or Good; or C-ACT2 improvement ≥3 points before and after omalizumab treatment | After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and serious adverse events | To evaluate safety of omalizumab among children with allergic asthma in China. | Throughout the study, approximately 2 years | 
| Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE) | Positive investigator's GETE is defined as restrospectively evaluated GETE are Excellent or Good. | After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in moderate-to-severe Asthma exacerbation | Moderate-to-severe asthma exacerbation is defined as worsening of asthma symptoms requiring doubling of baseline ICS dose and/or treatment with rescue systemic corticosteroids for ≥ 3 days. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in severe Asthma exacerbation | Severe asthma exacerbation is defined as requiring ER admission /hospitalization/ICU admission/mechanical ventilation with systemic corticosteroids for ≥ 3 days. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Average change from baseline in daily inhaled corticosteroids (ICS) dose | The dosage of inhaled corticosteroids (ICS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Average change from baseline in daily oral corticosteroids (OCS) dose | The dosage of oral corticosteroids (OCS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Percentage of patients that successfully stopped Oral Corticosteroids | Percentage of patients that successfully stopped Oral Corticosteroids after 4 to 6 months of treatment were reported | After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in Lung function using Forced Expiratory Volume in 1 Second (FEV1) | Lung function was assessed using Forced Expiratory Volume in 1 Second (FEV1) to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in FEV1% pred | Ratio of patient's actual results compared to predicted normal values, expressed as a percentage. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in FEV1/FVC | The FEV1/FVC ratio indicates how much air you can forcefully exhale. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in Peak Expiratory Flow (PEF) | Peak Expiratory Flow (PEF) is an objective measure of how well the lungs are functioning and can measure airway narrowing. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Change from baseline in Maximal mid-expiratory flow (MMEF) | Maximal mid-expiratory flow (MMEF) is a spirometric parameter reflecting airflow of large and small airways. | Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) | 
| Number of patients who received the recommended dosage instructions during the identification period | To describe the treatment pattern of omalizumab among children with allergic asthma in China. | Throughout the study, approximately 2 years | 
| Median time to discontinuation of the treatment | To describe the treatment pattern of Xolair among children with allergic asthma in China. | Throughout the study, approximately 2 years | 
| Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks | To describe the treatment pattern of omalizumab among children with allergic asthma in China. | Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020) | 
| Number of patients who discontinued omalizumab | To describe the treatment pattern of omalizumab among children with allergic asthma in China. | Throughout the study, approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omalizumab,, allergic asthma,, children,, real-world study