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
Overview
- Phase
- Not Applicable
- Intervention
- Omalizumab
- Conditions
- Allergic Asthma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Proportion of patients who responded to omalizumab
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Omalizumab
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
Intervention: Omalizumab
Outcomes
Primary Outcomes
Proportion of patients who responded to omalizumab
Time Frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
The responders were defined as patients with: 1. Investigator's Global Evaluation of Treatment Effectiveness (GETE) are Excellent or Good; or 2. C-ACT2 improvement ≥3 points before and after omalizumab treatment
Secondary Outcomes
- Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE)(After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Change from baseline in moderate-to-severe Asthma exacerbation(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(Baseline, 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)(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(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Change from baseline in FEV1/FVC(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Change from baseline in Maximal mid-expiratory flow (MMEF)(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Number of patients who discontinued omalizumab(Throughout the study, approximately 2 years)
- Number of adverse events and serious adverse events(Throughout the study, approximately 2 years)
- Change from baseline in severe Asthma exacerbation(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Percentage of patients that successfully stopped Oral Corticosteroids(After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Change from baseline in Peak Expiratory Flow (PEF)(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Change from baseline in FEV1% pred(Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020))
- Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks(Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020))
- Number of patients who received the recommended dosage instructions during the identification period(Throughout the study, approximately 2 years)
- Median time to discontinuation of the treatment(Throughout the study, approximately 2 years)