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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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