Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424523
• Other study ID #: CIGE025BCN01
• Status: Completed
• Start date: February 25, 2021
• Est. completion date: June 28, 2021

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Omalizumab
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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

External Links

•   Results for CIGE025BCN01 from the Novartis Clinical Trials Results Database