Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

June 29, 2022 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936-1080
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with allergic asthma treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Omalizumab
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
Drug: Omalizumab
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Throughout the study, approximately 2 years
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)
Time Frame: 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.
After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in moderate-to-severe Asthma exacerbation
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in severe Asthma exacerbation
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Percentage of patients that successfully stopped Oral Corticosteroids
Time Frame: 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
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)
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1% pred
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1/FVC
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Peak Expiratory Flow (PEF)
Time Frame: 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.
Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Maximal mid-expiratory flow (MMEF)
Time Frame: 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.
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
Time Frame: Throughout the study, approximately 2 years
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
Time Frame: Throughout the study, approximately 2 years
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
Time Frame: 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.
Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020)
Number of patients who discontinued omalizumab
Time Frame: Throughout the study, approximately 2 years
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Throughout the study, approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2021

Primary Completion (ACTUAL)

June 28, 2021

Study Completion (ACTUAL)

June 28, 2021

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (ACTUAL)

June 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025BCN01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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