Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
- Registration Number
- NCT05424523
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- Current participation in a clinical trial of any investigational treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Omalizumab Omalizumab Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
- Primary Outcome Measures
Name Time Method Proportion of patients who responded to omalizumab 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 Outcome Measures
Name Time Method 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) Positive investigator's GETE is defined as restrospectively evaluated GETE are Excellent or Good.
Change from baseline in moderate-to-severe Asthma exacerbation Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) 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.
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) 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.
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) 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.
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) 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.
Change from baseline in FEV1/FVC Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) The FEV1/FVC ratio indicates how much air you can forcefully exhale.
Change from baseline in Maximal mid-expiratory flow (MMEF) Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) Maximal mid-expiratory flow (MMEF) is a spirometric parameter reflecting airflow of large and small airways.
Number of patients who discontinued omalizumab Throughout the study, approximately 2 years To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Number of adverse events and serious adverse events Throughout the study, approximately 2 years To evaluate safety of omalizumab among children with allergic asthma in China.
Change from baseline in severe Asthma exacerbation Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) Severe asthma exacerbation is defined as requiring ER admission
/hospitalization/ICU admission/mechanical ventilation with systemic corticosteroids for ≥ 3 days.Percentage of patients that successfully stopped Oral Corticosteroids After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) Percentage of patients that successfully stopped Oral Corticosteroids after 4 to 6 months of treatment were reported
Change from baseline in Peak Expiratory Flow (PEF) Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) Peak Expiratory Flow (PEF) is an objective measure of how well the lungs are functioning and can measure airway narrowing.
Change from baseline in FEV1% pred Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020) Ratio of patient's actual results compared to predicted normal values, expressed as a percentage.
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) To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Number of patients who received the recommended dosage instructions during the identification period Throughout the study, approximately 2 years To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Median time to discontinuation of the treatment Throughout the study, approximately 2 years To describe the treatment pattern of Xolair among children with allergic asthma in China.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸East Hanover, New Jersey, United States